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 .
Application Status
Claims 1-24 are pending in this application. This communication is the first action on its merits. The Information Disclosure Statement (IDS) filed on 11/10/2025 has been considered by the office.
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.
Claims 19-20 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.
Claim 19 recites the limitation "the first lock member and second lock member" in line 2. There is insufficient antecedent basis for this limitation in the claim. There is no prior mention of this limitation within the preceding dependent and independent claims
Claim 20 recites the limitation "the first starburst engages the second starburst" in lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim. There is no prior mention of this limitation within the preceding dependent and independent claims
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.
Claims 1-8, 10-13, and 17-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moosmann (US 20220096195 A1).
Regarding Claim 1, Moosmann discloses a device for use in a medical procedure for stabilizing a head of a patient (See Fig. 1, head stabilization device 100) comprising a skull clamp (skull clamp 100) that comprises: a first arm and a second arm (See Fig 1, frame portions 104, 106), wherein each of the first arm and the second arm have an upright portion (See Fig. 1, generally upright portions 122, 124); a stabilization assembly connectable with each upright portion (See Fig. 1, stabilization assemblies 112, 114), wherein the stabilization assembly is configured to retain a stabilizing feature that is configured to contact the head of the patient (See Fig. 1, pins of 112 and 114 contact a head of a patient); a base defined by one or more lateral portions of a select one or both of the first and second arms, wherein the base defines a first axis (See Fig. 1, lateral portion 102 between frame portions 104, 106 defining a base); and an adjustment assembly located on the base of the skull clamp (See Fig. 1, adapter 300), wherein the adjustment assembly is configured to place the skull clamp in a select one of a first fixed state and a first adjustable state (“locking feature can be used to actuate adapter (300) between the open and closed states”; [0033]), wherein in the first adjustable state the skull clamp is adjustable about the first axis to move at least a portion of the skull clamp along a sagittal plane defined by the patient when in a prone or supine position (See Fig. 1, “skull clamp (100) is rotatable about the first longitudinal axis (LA1) of skull clamp (100) and about the second longitudinal axis (LA2) of joint assembly (200)”; [0032]).
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Regarding Claim 2, Moosmann discloses the device (head stabilization device 100) of claim 1, wherein the adjustment assembly comprises a first locking feature fixed with the base of the skull clamp (See Fig. 1-2, teeth 130) and a second locking feature selectively moveable along the base of the skull clamp (See Fig. 3B, teeth 334 of slide support 330).
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Regarding Claim 3, Moosmann discloses the device (head stabilization device 100) of claim 2, wherein the first locking feature comprises an interference fit with the second locking feature (See Fig. 7B, interference fit between teeth 130 and teeth 334).
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Regarding Claim 4, Moosmann discloses the device (head stabilization device 100) of claim 2, wherein the first locking feature comprises a first plurality of teeth (teeth 130) and the second locking feature comprises a second plurality of teeth (teeth 334).
Regarding Claim 5, Moosmann discloses the device (head stabilization device 100) of claim 2, wherein the adjustment assembly comprises a third locking feature that is rotatably connectable with the base of the skull clamp (See Fig. 6A – 7B, locking lever 350).
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Regarding Claim 6, Moosmann discloses the device (head stabilization device 100) of claim 5. wherein the third locking feature is threadably engaged with the base (See Fig. 11, locking member 1370 is threadably engaged with rod 1202 of joint assembly 1200).
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Regarding Claim 7, Moosmann discloses the device (head stabilization device 100) of claim 5, wherein the third locking feature is rotatable about the base and the second locking feature translates relative to the base upon rotation of the third locking feature (See Fig. 6A – 7B, rotation of locking lever 350 causes translation of slide support 330).
Regarding Claim 8, Moosmann discloses the device (head stabilization device 100) of claim 5, wherein the second locking feature comprises a tab and the third locking feature comprises a groove configured to receive the tab of the second locking feature (See Fig. 16, notch 1354 is engaged by projection 1349).
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Regarding Claim 10, Moosmann discloses the device (head stabilization device 100) of claim 5, wherein the second locking feature includes a tab (See Fig. 3A, flange 362) and the third locking feature includes a tab (See Fig. 16, edge of member 1350 protruding tab), wherein the tabs are configured to provide a gripping surface (“a flange (362) configured to be gripped by a user”; [0041], edge of 1350 can be gripped).
Regarding Claim 11, Moosmann discloses the device (head stabilization device 100) of claim 1, wherein the adjustment assembly is configured to adjust the skull clamp along the sagittal plane while maintaining the relative position of the base of the skull clamp to a table adapter that is configured to connect the skull clamp with a patient support table (See Fig. 1, “skull clamp (100) is rotatably adjustable in at least two directions to position head stabilization device (100) relative to table adapter (400)”; [0032]).
Regarding Claim 12, Moosmann discloses the device (head stabilization device 100) of claim 1 further comprising a position adapter (joint assembly 200) configured to selectively connect with the skull clamp at a first end, wherein the position adapter is further configured to place the skull clamp in a select one of a second fixed state and a second adjustable state, wherein in the second adjustable state the skull clamp is adjustable about a second axis transverse to the first axis (See Fig. 1, “Skull clamp (100) is coupled with adapter (300) which is coupled with joint assembly (200) such that skull clamp (100) is rotatably adjustable in at least two directions to position head stabilization device (100) relative to table adapter (400)”; [0032], axis is transverse to both LA1 and LA2).
Regarding Claim 13, Moosmann discloses the device (head stabilization device 100) of claim 12, wherein the positioning adapter comprises a slot configured to receive a flange of the second locking feature (See Fig. 4A, flanges 372 residing in channel 209).
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Regarding Claim 17, Moosman discloses the device (head stabilization device 100) of claim 12, wherein the position adapter comprises a lock assembly having a first lock member and a second lock member, wherein the first and second lock member are selectively engageable (teeth 203 and 377 engage each other) such that when engaged the skull clamp is in the second fixed state and when disengaged the skull clamp is in the second adjustable state (See Fig. 4A, “flange (372) includes engaging features or engaging members illustrated as teeth (377) positioned about a circumference of flange (372) that are configured to engage with engaging members or engaging features illustrated as teeth (203) of proximal joint (202)”; [0045])
Regarding Claim 18, Moosmann discloses the device (head stabilization device 100) of claim 17, wherein the first lock member and the second lock member have an interference fit when engaged (See Fig. 4A, teeth 203 and 377 engaging in an interference fit when locked).
Regarding Claim 19, Moosmann discloses the device (head stabilization device 100) of claim 12, wherein the first lock member and second lock member each comprise a plurality of teeth wherein the pluralities of teeth are selectively engageable such that when engaged the skull clamp is in the second fixed state and when disengaged the skull clamp is in the second adjustable state (See Fig. 4A, “flange (372) includes engaging features or engaging members illustrated as teeth (377) positioned about a circumference of flange (372) that are configured to engage with engaging members or engaging features illustrated as teeth (203) of proximal joint (202)”; [0045]).
Regarding Claim 20, Moosmann discloses the device (head stabilization device 100) of claim 19, wherein the positioning adapter comprises a wedge member configured to translate the lock member so that the first starburst engages the second starburst of the flange (See Fig. 11, knob 1204 turns bore 1202 engaging starbursts 1377 and 1203).
Regarding Claim 21, Moosmann discloses a device for use in a medical procedure for stabilizing a head of a patient (See Fig. 1, head stabilization device 100) comprising a skull clamp (skull clamp 100) and a position adapter (joint assembly 200), wherein the skull clamp comprises: a. a first arm and a second arm (See Fig 1, frame portions 104, 106), wherein each of the first arm and the second arm have an upright portion (See Fig. 1, generally upright portions 122, 124); b. a stabilization assembly connectable with each upright portion (See Fig. 1, stabilization assemblies 112, 114), wherein the stabilization assembly is configured to retain a stabilizing feature that is configured to contact the head of the patient (See Fig. 1, pins of 112 and 114 contact a head of a patient); and c. a base defined by one or more lateral portions of a select one or both of the first and second arms, wherein the base defines a first axis (See Fig. 1, lateral portion 102 between frame portions 104, 106 defining a base); and wherein the position adapter is configured to selectively connect with the base of skull clamp, wherein the position adapter is configured to place the skull clamp in a select one of a fixed state and an adjustable state, wherein in the adjustable state the skull clamp is adjustable about a second axis transverse to the first axis (See Fig. 1, “Skull clamp (100) is coupled with adapter (300) which is coupled with joint assembly (200) such that skull clamp (100) is rotatably adjustable in at least two directions to position head stabilization device (100) relative to table adapter (400)”; [0032], axis is transverse to both LA1 and LA2).
Regarding Claim 22, Moosmann discloses the device (head stabilization device 100) of claim 21, wherein the position adapter comprises a slot (channel 209), and wherein the device comprises a connection member having a flange (flanges 372), wherein the slot of the positioning adapter is configured to receive the flange of the connection member, wherein engagement of the flange and the slot is configured to transfer the weight of the head of the patient to a table adapter connectable with the position adapter (See Fig. 4A, flanges 372 reside within channel 209, connecting the joint assembly 202 adapter 300 and device 100, transfer the load to the table adapter 400).
Regarding Claim 23, Moosmann discloses the device (head stabilization device 100) of claim 22, wherein the flange includes a first engaging feature (See Fig. 4A, flanges 372 having teeth 377), and the position adapter includes a second engaging feature configured to selectively engage with the first engaging feature (See Fig. 4A, channel 209 comprising adjacent teeth 203), wherein the engagement of the flange and the slot is configured to transfer the weight of the head of the patient to the table adapter connectable with the position adapter when the first and second engaging features are disengaged (See Fig. 4A, flanges 372 reside within channel 209, connecting the joint assembly 202 adapter 300 and device 100, transfer the load to the table adapter 400).
Regarding Claim 24, Moosmann discloses a method of adjusting a skull clamp (skull clamp 100) along a sagittal plane defined by a patient when in the prone or supine position (See Fig. 1, “head stabilization system (10) that can be used to stabilize a patient's head for a medical procedure”; [0032]), the skull clamp having (a) a first arm and a second arm (See Fig 1, frame portions 104, 106) each with an upright portion (See Fig. 1, generally upright portions 122, 124), (b) a stabilization assembly connectable with each upright portion (See Fig. 1, stabilization assemblies 112, 114), (c) a base defined by one or more lateral portions of a select one or both of the first and second arms (See Fig. 1, lateral portion 102 between frame portions 104, 106 defining a base), (d) an axis defined by the base wherein the axis extends perpendicular to the sagittal plane (See Fig. 1, perpendicular axis), and (e) an adjustment assembly connectable with the base (See Fig. 1, adapter 300) where the adjustment assembly includes (i) a first locking feature fixed to a portion of the base (See Fig. 1-2, teeth 130), (ii) a second locking feature moveable relative to the base (See Fig. 3B, teeth 334 of slide support 330), the second locking feature selectively connectable with the first locking feature (See Fig. 7B, connection between teeth 130 and teeth 334), and (iii) a third locking feature threadably connected with the base (See Fig. 11, locking member 1370 is threadably engaged with rod 1202 of joint assembly 1200), the third locking feature connectable with the second locking feature (See Fig. 6A – 7B, locking lever 350), the method steps comprising: a. rotating the third locking feature about the base to translate and separate the second locking feature from the first locking feature to place the skull clamp in an adjustable state (See Fig. 6A – 7B, rotation of locking lever 350 causes translation of slide support 330); b. rotating the first and second arms of the skull clamp about the axis to a desired position, wherein the rotation moves the skull clamp along the sagittal plane (See Fig. 1, rotation of portions 104, 106 along axis LA1); and c. rotating the third locking feature about the base to translate and engage the second locking feature with the first locking feature to place the skull clamp in a fixed state where the skull clamp is not adjustable about the axis and along the sagittal plane (“locking bar (360) is translated upward relative to slide support (330) to insert tab (364) of locking bar (360) within channel (352) of locking lever (350). Locking bar (360) thereby locks the position of locking lever (350) relative to slide support (330). Accordingly, adapter (300) is in a closed and locked state”; [0049], “the two degrees of freedom—coinciding to rotational adjustments about longitudinal axes (LA1, LA2)—remain adjustable at the same time so that adjustments can be made to either or both before either or both are secured or moved to their non-adjustable state”; [0050]).
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 9, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Moosmann (US 20220096195 A1) in view of Forst (US 20210236321 A1).
Regarding Claim 9, Moosmann discloses the device (head stabilization device 100) of claim 8.
Moosmann teaches the second locking feature is configured to translate along the base upon rotation of the third locking feature relative to the base (See Fig. 6A-7B, rotation of locking lever 350 causes translation of slide support 330).
Moosmann fails to explicitly disclose wherein the tab is configured to freely slide within the groove when the third locking feature is rotated about the base,
However, Forst teaches wherein the tab is configured to freely slide within the groove when the third locking feature is rotated about the base (See Fig. 2A-2B, alignment feature 416 slides within groove 402 when actuator 402 is rotated).
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Accordingly, it would have been obvious to one of ordinary skill in the art before the claimed invention was effectively filed to have modified the invention of Moosmann by adding the tab of Forst. One of ordinary skill in the art would have been motivated to make this modification to “maintain the alignment of elongated shafts”; (Forst, [0057]). All of the claimed elements were known in the prior art and one skilled in the art could have made this modification with a reasonable expectation of success and one of ordinary skill in the art would have recognized that the results of the modification were predictable.
Regarding Claim 14, Moosmann discloses the device (head stabilization device 100) of claim 13.
Moosmann fails to explicitly disclose wherein the positioning adapter comprises a bolt and the flange comprises a recess configured to receive the bolt, wherein the engagement of the bolt with the recess and the slot with the flange maintains a connection between the positioning adapter and the second locking feature with the skull clamp in the second adjustable state.
However, Forst teaches wherein the positioning adapter comprises a bolt and the flange comprises a recess configured to receive the bolt, wherein the engagement of the bolt with the recess and the slot with the flange maintains a connection between the positioning adapter and the second locking feature with the skull clamp in the second adjustable state (See Fig. 2A-2C and 3, wherein actuator 402 and locking feature 404 are connected by a pinned connection, and when biased by the spring both comprise features that lock protrusions within openings or recesses to lock the frame adjustment feature 400).
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Accordingly, it would have been obvious to one of ordinary skill in the art before the claimed invention was effectively filed to have modified the invention of Moosmann by adding the mechanism of Forst. One of ordinary skill in the art would have been motivated to make this modification “such that frame portions (102, 104) may be adjusted relative to each other and then secured to prevent opening of frame portions (102, 104) once a desired position or arrangement has been reached”; (Forst, [0056]). All of the claimed elements were known in the prior art and one skilled in the art could have made this modification with a reasonable expectation of success and one of ordinary skill in the art would have recognized that the results of the modification were predictable.
Regarding Claim 15, Moosmann, as modified, teaches the device (head stabilization device 100) of claim 14.
Moosmann fails to explicitly teach wherein positioning adapter comprises a spring configured to bias the bolt into the recess of the flange.
However, Frost teaches wherein positioning adapter comprises a spring configured to bias the bolt into the recess of the flange (See Fig. 3, biasing spring).
Accordingly, it would have been obvious to one of ordinary skill in the art before the claimed invention was effectively filed to have modified the invention of Moosmann by adding the spring of Forst. One of ordinary skill in the art would have been motivated to make this modification “such that frame portions (102, 104) may be adjusted relative to each other and then secured to prevent opening of frame portions (102, 104) once a desired position or arrangement has been reached”; (Forst, [0056]). All of the claimed elements were known in the prior art and one skilled in the art could have made this modification with a reasonable expectation of success and one of ordinary skill in the art would have recognized that the results of the modification were predictable.
Regarding Claim 16, Moosmann, as modified, teaches the device of claim 14.
Moosmann fails to explicitly teach wherein the positioning adapter comprises a release lever configured to selectively retract the bolt from the recess.
However, Frost teaches wherein the positioning adapter comprises a release lever configured to selectively retract the bolt from the recess (See Fig. 2A-2C and 3, rotating actuator 402 towards the spring will compress the spring and retract locking feature 412 out of opening 118).
Accordingly, it would have been obvious to one of ordinary skill in the art before the claimed invention was effectively filed to have modified the invention of Moosmann by adding the lever of Forst. One of ordinary skill in the art would have been motivated to make this modification “such that frame portions (102, 104) may be adjusted relative to each other and then secured to prevent opening of frame portions (102, 104) once a desired position or arrangement has been reached”; (Forst, [0056]). All of the claimed elements were known in the prior art and one skilled in the art could have made this modification with a reasonable expectation of success and one of ordinary skill in the art would have recognized that the results of the modification were predictable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 9216126 B2: Schuele discloses a table adapter connectable to a table, a joint assembly connectable to the table adapter, and a head fixation device in the form of a skull clamp connectable to the joint assembly.
US 20200261179 A1: Schuele discloses a skull clamp head fixation device wherein the clamps are translatable in both the horizontal and vertical directions.
US 20080072381 A1: Rolfes discloses a head support base unit rotatable about the sagittal plane.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE SAMUEL GINES whose telephone number is (571)270-0968. The examiner can normally be reached Monday - Friday 7:30am - 5:00pm.
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, Justin Mikowski can be reached at (571) 272-8525. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GEORGE SAMUEL GINES/Examiner, Art Unit 3673
/JUSTIN C MIKOWSKI/Supervisory Patent Examiner, Art Unit 3673
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