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 .
In view of the Notice of Appeal Brief filed on 01/26/2026, PROSECUTION IS HEREBY REOPENED. A new grounds of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/ALIREZA NIA/ Supervisory Patent Examiner, Art Unit 3786
Response to Amendment
The Appeal Brief filed 01/26/2026 is acknowledged by the examiner.
Claims 26-46 are currently pending and are under examination.
Response to Arguments
Applicant’s arguments with respect to claim(s) 26-46 have been considered but are moot because the new ground of rejection. A new reference Schuele ‘937 is disclosed as having cylindrical lateral portions, therefore, the arguments regarding the previous Schule reference are moot.
Applicant's arguments filed 01/26/2026 have been fully considered but they are not persuasive.
Applicant’s argument regarding Radina reference: The combined art of record here lacks any teaching or suggestion for why one would modify the art of record to arrive at the above-noted claim limitations. The sole reasoning the office says for why such a modification would be obvious is to provide a smoother and less bulky head stabilization device. It should be noted that nowhere in the combined art of record is it stated or suggested that the frame of a head stabilization device should be smoother or less bulky. Modification is based on pure hindsight. Examiner has not established a prima facie case of obviousness for claim 26 and its dependent claims based on Radina in view of Schule and in view of Schuele because the Examiner's reasonings are based on impermissible hindsight.
Examiner’s response: In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Further, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation to modify the lateral portions of Radina is disclosed to provide more uniform stress distribution making the device more durable.
Claim Objections
Claims 27, 32, 35, 36, and 38 are objected to because of the following informalities:
Regarding claim 27, “the stabilization assembly imparts onto the patient” in line 9 should be recited as “the stabilization assembly is configured to impart onto the patient.”
Regarding claim 32, “the stabilization assembly imparts onto the patient” in lines 2-3 should be recited as “the stabilization assembly is configured to impart onto the patient.”
Regarding claim 35, “the stabilization assembly imparts onto the patient” in line 2 and in lines 3-4 should be recited as “the stabilization assembly is configured to impart onto the patient”.
Regarding claim 36, “the stabilization assembly imparts onto the patient” in line 5 should be recited as “the stabilization assembly is configured to impart onto the patient.”
Regarding claim 38, “the stabilization assembly imparts onto the patient” in lines 4-5 should be recited as “the stabilization assembly is configured to impart onto the patient.”
Appropriate correction is required.
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: “adjustment feature” in claim 37, which is interpreted as a feature that adjusts the relative spacing between the first and second frame portions, see [00048] of applicant’s specification.
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.
Specification
The disclosure is objected to because of the following informalities: Claim 26 states “the interface is positioned along the length defined by the lateral portions of the frame assembly and oriented transverse to a longitudinal axis defined by the length of the lateral portions of the frame assembly,” however, Applicant’s specification only mentions the interface in paragraph [000093] on page 20.
Appropriate correction is required.
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 27-40 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 27 recites the limitation "the stabilization feature" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 41 recites the limitation "the stabilization feature" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claims 28-40 are rejected for depending on a previously rejected claim.
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.
(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) 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schuele (referred to as “Schuele ‘937”) (US 2015/0327937 A1).
Regarding claim 26, Schuele '937 discloses a device for stabilizing a head of a patient (see Fig. 1 and Abstract, and [0002], the device comprising:
(a) a frame assembly (20, 30) having a first frame portion (20) and a second frame portion (30), the first and second frame portions are selectively movable relative to one another to adjust a space between the first and second frame portions (see [0022] which discusses how the first arm 20 and second arm 30 are selectively movable relative to one another to adjust a space between them, see Figs. 1-2), wherein each of the first and second frame portions comprises an upright portion (21, 31) and a lateral portion (22, 32) (see Figs. 1-2 and [0019]-[0020]; the first arm 20 has an upright portion 21 and lateral portion 22, and second arm 30 has an upright portion 31 and lateral portion 32), wherein the upright portions (21, 31) each are configured to receive a stabilization assembly (12, 14) (see Figs. 1-2 and [0019]-[0020]; the upright portions 21 and 31 each receive a first pin assembly 12 and a second pin assembly 14, respectively), and wherein the lateral portions (22, 32) define a length and the lateral portions (22, 32) have a cylindrical shape along at least a portion of the length (see Figs. 1-2; the lateral portions 22, 32 each define a length horizontally, and the arms 20, 30 may have a cylindrical shape, see [0040], and thus the lateral portions 22, 32 may have a cylindrical shape along at least a portion of the length); and
(b) an interface (40, 42) configured to attach a skull clamp (10), directly or indirectly, with a patient support structure (see Figs. 1-4 and [0024]; starburst interfaces 40,42 are configured to attach skull clamp 10, directly or indirectly, with an operating table which is a patient support structure), wherein the interface (40, 42) is positioned along the length defined by the lateral portions (22, 32) of the frame assembly (20,30) and oriented transverse to a longitudinal axis defined by the length of the lateral portions (22, 32) of the frame assembly (20, 30) (see Figs. 1-4 and [0024]; the starburst interfaces 40,42 are positioned along the length defined by the lateral portions 22,32, and the starburst interfaces 40,42 are oriented transverse to a longitudinal axis defined by the length of the lateral portions 22, 32, see Annotated Fig. 1 of Schuele '397 that has the longitudinal axis defined by the length of the lateral portions 22, 32 shown via the horizontal dotted line and the interface oriented transverse as shown via the vertical dotted line).
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Annotated Fig. 1 of Schuele ‘937.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 42-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schuele ‘937 in view of Moffatt (9,204,818 B2).
Regarding claim 42, Schuele '937 discloses the invention as discussed in claim 26. Schuele ‘937 further discloses an actuator (16) (see [0023] which states that the locking pin 16, which is an actuator as the locking pin 16 is manually moved to adjust the width of the arms 20, 30, see [0022], can be repositioned to be at a side of the skull clamp 10).
Schuele '937 is silent on a first body having a first end and a second end, wherein the first end is configured to connect with the stabilization assembly of the stabilization device; and the actuator, directly or indirectly connectable with the first body, wherein the actuator is configured to cause a torque to be applied on the first body, wherein an increase in the torque on the first body increases a tension within the first body, wherein the first body applies an increase in force to the stabilization assembly in response to the increase in tension within the first body.
However, Moffatt teaches an analogous device (50) for stabilizing a head of a patient (see Fig. 4), and a first body (65) having a first end and a second end (see Figs. 4-5; screw 65 is a first body as it is a physical structure and screw 65 has a first end which is an end on the left side in Fig. 4 and a second which is an end that is on the right side and attached to hand wheel 66), wherein the first end is configured to connect with the stabilization assembly (55, 56) of the stabilization device (50) (see Figs. 4-5; the first end which is the end on the left side of screw 65 is configured to indirectly connect with clamp member 56 via leg 53 and 54); and an actuator (66W), directly or indirectly connectable with the first body (65) (see Figs. 4-9; hand wheel portion 66W is an actuator as it is a manually graspable hand wheel, and hand wheel portion 66W is indirectly connectable with screw 65 as seen in Fig. 8), wherein the actuator (66W) is configured to cause a torque to be applied on the first body (65) (see Fig. 4; hand wheel portion 66W is rotated which causes screw 65 to be rotated, see Col. 14 lines 32-36), wherein an increase in the torque on the first body (65) increases a tension within the first body (65) (see Fig. 4; an increase in torque on screw 65 via hand wheel portion 66W increases a tension within screw 65 as the screw acts to pull on nut component 75 to pull the clamp into tension on the head of the patient), wherein the first body (65) applies an increase in force to the stabilization assembly (55,56) in response to the increase in tension within the first body (65) (see Fig. 4; screw 65 applies an increase in force to the clamp members 55,56 in response to the increase in tension within the screw 65 as the screw 65 is rotated to increase the pressure on the skull of a user via clamp members 55,56, see Col. 14 lines 32-36), providing the adjustment system out of the field of images of the skull when taken from the top or bottom, and also provides smooth incremental adjustments offering better alignment.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the actuator (16) in the device of Schuele '937 with a first body (65) having a first end and a second end, wherein the first end is configured to connect with the stabilization assembly of the stabilization device and an actuator (66W), directly or indirectly connectable with the first body, wherein the actuator is configured to cause a torque to be applied on the first body, wherein an increase in the torque on the first body increases a tension within the first body, wherein the first body applies an increase in force to the stabilization assembly in response to the increase in tension within the first body as taught by Moffatt to have provided an improved stabilization device that keeps the adjustment system out of the field of images of the skull when taken from the top or bottom, and also provides smooth incremental adjustments offering better alignment, as the operation of Schuele ‘937 would not change and thus would remain operable.
Regarding claim 43, Schuele '937 in view of Moffat discloses the invention as discussed in claim 42. Schuele '937 in view of Moffat further discloses wherein the dimensions of the first body (65 of Moffatt) remain constant when the torque is applied on the first body (65 of Moffatt) and when the tension increases within the first body (65 of Moffatt) (see Figs. 4-5 of Moffatt; the dimensions of screw 65 of Moffatt remain constant when torque is applied on the screw 65 of Moffatt and when the tension increases within screw 65 of Moffatt).
Regarding claim 44, Schuele '937 in view of Moffatt discloses the invention as discussed in claim 42. Schuele '937 in view of Moffatt further discloses a second body (66A,66B,66M of Moffatt) connected with the first body (65 of Moffatt) at the second end in a keyed manner such that the first body (65 of Moffatt) and the second body (66A,66B,66M of Moffatt) are prevented from rotating relative to one another (see Figs. 4-9 of Moffatt; cylindrical insert portion 66A+66B+collar 66M of Moffatt make up a second body and is connected to screw 65 of Moffatt at the second end, as the second end is the end of screw 65 that is on the right side in Fig. 4 of Moffatt, and is connected in a keyed manner as cylindrical insert portion 66A of Moffatt comprises receptacle 66C of Moffatt as seen in Fig. 7 of Moffatt which is a splined recess, see Col. 15 lines 17-25 of Moffatt, and thus the splined recess engages with the splined heads of screw 65 to be connected in a keyed manner such that they are prevented from rotating relative to one another, see Col. 15 lines 17-31 of Moffatt, Col. 13 lines 16-20 of Moffatt, and Col. 14 lines 8-12 of Moffatt), wherein the second body (66A+66B+66M of Moffatt) and the first body (65 of Moffatt) are oriented substantially perpendicular to one another (see Annotated Fig. 8 of Moffatt; the collar 66M of Moffatt of the second body is oriented perpendicular to the screw 65 of Moffatt as seen in Annotated Fig. 8 of Moffatt via the vertical and horizontal lines).
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Annotated Fig. 8 of Moffatt.
Regarding claim 45, Schuele '937 in view of Moffatt discloses the invention as discussed in claim 44. Schuele '937 in view of Moffatt further discloses wherein the actuator (66W of Moffatt) is directly or indirectly connectable with the second body (66A,66B,66M of Moffatt) (see Figs. 6-9 of Moffatt; the hand wheel portion 66W of Moffatt is directly connectable with the cylindrical portion 66A,66B,66M of Moffatt), wherein the actuator (66W of Moffatt) is configured to cause torque to be applied on the first body (65 of Moffatt) by causing the torque to be applied on the second body (66A,66B,66M of Moffatt) and transferred to the first body (65 of Moffatt) such that the tension within the first body (65 of Moffatt) increases (see Figs. 4-9 of Moffatt and Col. 14 lines 32-36 of Moffatt; the hand wheel portion 66W of Moffatt is configured to cause the torque to be applied on the screw 65 of Moffatt by causing the torque to be applied to cylindrical portion 66A,66B+collar 66M of Moffatt as these portions are all connected to each other and then transferred to screw 65 such that the tension within screw 65 of Moffatt increases).
Regarding claim 46, Schuele '937 in view of Moffatt discloses the invention as discussed in claim 45. Schuele '937 in view of Moffatt further discloses wherein the dimensions of the second body (66A,66B,66M of Moffatt) remain constant when the torque is applied on the second body (66A,66B,66M of Moffatt) causing the increase in tension within the first body (65 of Moffatt) (see Figs. 4-9 of Moffatt; the dimensions of cylindrical portion 66A,66B+collar 66M of Moffatt remians constant when torque is applied to it causing the increase in tension within screw 65 of Moffatt).
Claim(s) 26-28, 31-32, 34-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radina et al. (referred to as “Radina”) (US 9,844,482 B2) in view of Schuele ‘937.
Regarding claim 26, Radina discloses a device for stabilizing a head of a patient (see Fig. 2) (see Col. 1 lines 11-12; a medical head holder is a device to keep a patient’s head stabilized or steady), the device comprising:
(a) a frame assembly having a first frame portion and a second frame portion (see Annotated Fig. 2 of Radina; the first frame portion and second frame portion are labeled in Annotated Fig. 2 of Radina and are L-shaped frame sections and make up the frame assembly), the first and second frame portions are selectively movable relative to one another to adjust a space between the first and second frame portions (see Annotated Fig. 2 of Radina; lever 22 has the same function as lever 16 in the first embodiment shown in Fig. 1, and thus lever 22 allows for the first and second frame portions to be selectively movable relative to one another to adjust a space between the first and second frame portions when lever 22 is in a fully open position, the two frames can be moved toward or away from each other and when lever 22 is in a fully closed position, see Col. 10 lines 10-12 and Col. 8 lines 30-36), wherein each of the first and second frame portions comprise an upright portion and a lateral portion (see Annotated Fig. 2 of Radina), wherein the upright portions each are configured to receive a stabilization assembly (1, 1a, 2, 2a) configured to contact the head of the patient (see Annotated Fig. 2 of Radina; the upright portions labeled in the annotated Fig. 2 each are configured to receive a stabilization assembly 1, 1a, 2, 2a which are a stabilization assembly as they are configured to contact the head of a patient as seen in Fig. 2 in order to hold the patient’s head steady), wherein the lateral portions define a length (see Annotated Fig. 2 of Radina; the lateral portions labeled in annotated fig. 2 define a length).
Radina is silent on the lateral portions have a cylindrical shape along at least a portion of the length; and an interface configured to attach a skull clamp, directly or indirectly, with a patient support structure, wherein the interface is positioned along the length defined by the lateral portions of the frame assembly and oriented transverse to a longitudinal axis defined by the length of the lateral portions of the frame assembly.
However, Schuele ‘937 teaches an analogous head stabilization device (10), and analogous lateral portions (22,32) (see Figs. 1-2 and [0019]-[0020]; first arm 20 has a lateral portion 22 and second arm 30 has a lateral portion 32), and wherein the lateral portions (22, 32) have a cylindrical shape along at least a portion of the length (see Figs. 1-2; the arms 20,30 may have a cylindrical shape, see [0040], and thus the lateral portions 22, 32 may have a cylindrical shape along at least a portion of the length); and an interface (40,42) configured to attach a skull clamp (10), directly or indirectly, with a patient support structure (see Figs. 1-4 and [0024]; starburst interfaces 40,42 are configured to attach skull clamp 10, directly or indirectly, with an operating table which is a patient support structure), wherein the interface (40,42) is positioned along the length defined by the lateral portions (22,32) of the frame assembly (20,30) and oriented transverse to a longitudinal axis defined by the length of the lateral portions (22, 32) of the frame assembly (20, 30) (see Figs. 1-4 and [0024]; the starburst interfaces 40,42 are positioned along the length defined by the lateral portions 22,32, and the starburst interfaces 40,42 are oriented transverse to a longitudinal axis defined by the length of the lateral portions 22, 32, see Annotated Fig. 1 of Schuele '397 that has the longitudinal axis defined by the length of the lateral portions 22, 32 which is the horizontal dotted line and a vertical dotted line representing the interfaces 40,42 oriented transverse to the longitudinal axis), providing a more uniform stress distribution making the device more durable, and an attachment feature so that a user is able to easily attach other structures to the head stabilization device, such as an operating table (see [0024]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of each of the lateral portions in the device of Moffatt as In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), the court held that changes in shape was a matter of choice which a person of ordinary skill in the art would have found obvious, see MPEP 2144.04 IV B, to be a cylindrical shape along at least a portion of the length as taught by Schuele ‘937, and to have provided one of the lateral portions in the device of Radina with an interface (40,42) configured to attach a skull clamp, directly or indirectly, with a patient support structure, wherein the interface is positioned along the length defined by the lateral portions of the frame assembly and oriented transverse to a longitudinal axis defined by the length of the lateral portions of the frame assembly as taught by Schuele ‘937 to have provided an improved head stabilization device that has a more uniform stress distribution making the device more durable, and that provides an attachment feature so that a user is able to easily attach other structures to the head stabilization device, such as an operating table (see [0024]).
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Annotated Fig. 2 of Radina.
Regarding claim 27, Radina in view of Schule further in view of Schuele ‘765 discloses the invention as discussed in claim 26. Radina in view of Schule further in view of Schuele ‘765 further discloses a tensioning feature (7, 18, 19, 20, 21, 22 of Radina) configured to receive the stabilization assembly (1, 1a, 2, 2a of Radina) at a first location (see Fig. 2 of Radina; force applicator 7 of Radina, which is shown in Fig. 1 of Radina but is already detached in Fig. 2 of Radina, see Col. 9 lines 56-61 of Radina, + push bars 18,19 + levers 20,21,22 make up a tensioning feature as force applicator 7 increases/decreases the force acting on the patient’s head as the engagement member 2 of Radina is able to move toward/away from engagement member 1 of Radina, and push bars 18, 19+levers 20,21,22 also increases/decreases the force acting on the patient’s head as the levers allow the engagement members 1,2 to be moved towards/away from each other, and force applicator 7 of Radina is configured to indirectly receive engagement member 2 of Radina at a first location), the tensioning feature (7, 18, 19, 20, 21, 22 of Radina) further includes a second location spaced a distance away from the first location such that the second location is spaced away from the stabilization assembly (1, 1a, 2, 2a of Radina), the tensioning feature (7, 18, 19, 20, 21, 22 of Radina) including an actuator (7, 20, 21 of Radina) positioned at the second location such that the actuator (7, 20, 21 of Radina) is spaced away from the stabilization assembly (1, 1a, 2, 2a of Radina) (see Figs. 1-2 of Radina; the tensioning feature includes force applicator 7 of Radina, as seen in Fig. 1 of Radina, and levers 20,21 of Radina as seen in Fig. 2 of Radina which are each positioned at a second location that is spaced a distanced away from the first location), the tensioning feature (7, 18, 19, 20, 21, 22 of Radina) including an elongated member (7a, 18 of Radina) extending from the actuator (7, 20, 21 of Radina) to the stabilization assembly (1, 1a, 2, 2a of Radina) (see Figs. 1-2 of Radina; push bar 18 of Radina is an elongated members and extends from levers 20, 21 of Radina to engagement member 2), the actuator (7, 20, 21 of Radina) being configured to cause movement of the elongated member (7a, 18 of Radina) relative to the stabilization assembly (1, 1a, 2, 2a of Radina) when the stabilization feature is in contact with the patient to adjust an amount of force the stabilization assembly imparts onto the patient (see Figs. 1-2 of Radina; when gripping means 8 of Radina of the force applicator 7 of Radina is rotated and moves to the left or right, the gripping means 8 of Radina is configured to cause cylinder 7a of Radina to move to the left or right relative to the stabilization assembly 1, 1a, 2, 2a of Radina when the head pins 1a, 2a of Radina are in contact with the patient’s head to adjust an amount of force the stabilization assembly imparts onto the patient, see Col. 8 lines 50-60 of Radina).
Regarding claim 28, Radina in view of Schule further in view of Schuele ‘765 discloses the invention as discussed in claim 26. Radina in view of Schule further in view of Schuele ‘765 further discloses at least a portion of the elongated member 7, 18 of Radina) being configured to bend in response to an increase in force imparted to the stabilization assembly (1, 1a, 2, 2a of Radina) (see Fig. 2 and Col. 9 lines 65-67 et seq. Col. 10 lines 1-9 of Radina; at least a portion of push bar 18 of Radina is able to bend/move in response to an increase in force imparted to the stabilization assembly 1, 1a, 2, 2a of Radina).
Regarding claim 31, Radina in view of Schule further in view of Schuele ‘765 discloses the invention as discussed in claim 27. Radina in view of Schule further in view of Schuele ‘765 further discloses the actuator (7, 20, 21 of Radina) further comprising a rod (19 of Radina) and a lock feature (21 of Radina) configured to releasably hold the rod (19 of Radina) in a selected position of a plurality of predetermined positions (see Fig. 2 of Radina; push bar 19 of Radina is a rod as it is a thin straight piece or bar and lever 21 of Radina is a lock feature as lever 21 of Radina can be in a closed position which is a securely locked position, and lever 21 of Radina releasably holds push bar 19 of Radina in a selected position of a plurality of predetermined positions relative to the frame of lever 20 of Radina, as if lever 21 of Radina is in an open position, push bar 19 of Radina which is connected to lever 22 of Radina which functions the same as lever 16 of Radina, then lever 22 of Radina can assume three different positions: closed, fully open, and half-open position, which affects the position of push bar 19 of Radina as they are connected, see Col. 10 lines 10-12 and Col. 8 lines 9-12 of Radina).
Regarding claim 32, Radina in view of Schule further in view of Schuele ‘765 discloses the invention as discussed in claim 27. Radina in view of Schule further in view of Schuele ‘765 further discloses a force indication feature (11 of Radina) configured to indicate the amount of force the stabilization assembly (1, 1a, 2, 2a of Radina) imparts onto the patient (see Fig. 1 and Col. 8 lines 60-66 of Radina; force indicator 11 of Radina is a force indication feature as the applicant’s specification discloses the force indication feature to be a scale, see [00073] on page 13 of applicant’s specification, and force indicator 11 of Radina is interpreted as a scale as force indicator 11 of Radina is configured to indicate the amount of force the stabilization assembly 1, 1a, 2, 2a of Radina imparts onto the patient and thus correlates the amount of force to a distance in the same manner of a scale).
Regarding claim 34, Radina in view of Schule further in view of Schuele ‘765 discloses the invention as discussed in claim 27. Radina in view of Schule further in view of Schuele ‘765 further discloses the tensioning feature (7, 18, 19, 20, 21, 22 of Radina) being configured to adjust the amount of force the stabilization assembly (1, 1a, 2, 2a of Radina) imparts onto the patient while maintaining a relative position of the first and second frame portions such that the space between the first and second frame portions is unchanged (see Annotated Fig. 2 of Radina, and Figs. 1-2 of Radina; force applicator 7 of Radina, which can be detached from cylinder 7a of Radina and therefore is not shown in Fig. 2 as it has already been detached, see Col. 9 lines 56-61, and thus force applicator 7 of Radina adjusts the amount of force engagement member 2 imparts onto the patient while the relative positions of and space between the first and second frame portions is unchanged, as lever 22 of Radina changes the space between the frame portions, not force applicator 7 of Radina, see Col. 8 lines 41-67 et seq. Col. 9 lines 1-2 of Radina).
Regarding claim 35, Radina in view of Schule further in view of Schuele ‘765 discloses the invention as discussed in claim 27. Radina in view of Schule further in view of Schuele ‘765 further discloses the tensioning feature (7, 18, 19, 20, 21, 22 of Radina) being configured to adjust the amount of force the stabilization assembly (1, 1a, 2, 2a of Radina) imparts onto the patient while the relative position of the first and second frame portions changes as the amount of force the stabilization assembly (1, 1a, 2, 2a of Radina) imparts onto the patient is adjusted such that the space between the first and second frame portions is changed (see Annotated Fig. 2 of Radina and Figs. 1-2 of Radina; lever 22 of Radina has the same function as lever 16 of Radina shown in Fig. 1 of Radina, and thus lever 22 of Radina allows for the first and second frame portions to be selectively movable relative to one another to adjust a space between the first and second frame portions when lever 22 of Radina is in a fully open position, the two frame portions can be moved towards or away from each other and when lever 22 of Radina is in a fully closed position, and thus lever 22 of Radina, which is part of the tensioning feature, is configured to adjust the amount of force engagement members 1,2 of Radina impart onto the patient while the space between the first and second frame portions changes, see Col. 10 lines 10-12 of Radina and Col. 8 lines 30-36 of Radina).
Regarding claim 36, Radina in view of Schule further in view of Schuele ‘765 discloses the invention as discussed in claim 27. Radina in view of Schule further in view of Schuele ‘765 further discloses wherein the tensioning feature (7, 18, 19, 20, 21, 22 of Radina) comprises a body (see Fig. 1 of Radina; the force applicator 7 of Radina is part of the tensioning feature and comprises a body which is the entire frame of the force applicator as shown in Fig. 1 of Radina, as the force applicator 7 of Radina is detached in Fig. 2 of Radina), wherein the actuator (7, 20, 21 of Radina) is configured to move the elongated member (7a, 18 of Radina) relative to the body to transfer a force to the elongated member (7a, 18 of Radina) (see Figs. 1-2 and Col. 8 lines 50-60 of Radina; the force applicator 7 of Radina is configured to move cylinder 7a of Radina relative to the frame of the force applicator 7 of Radina in order to transfer a force to the cylinder 7a of Radina as the gripping means 8 of Radina of force applicator 7 of Radina acts translationally on cylinder 7a), and wherein the elongated member (7a, 18 of Radina) is configured to transfer at least a portion of the force to the stabilization assembly (1, 1a, 2 2a of Radina) to increase the amount of force the stabilization assembly (1, 1a, 2, 2a of Radina) imparts onto the patient (see Figs. 1-2 and Col. 8 lines 50-60 of Radina; the gripping means 8 of Radina acts translationally on the cylinder 7a of Radina and then the cylinder 7a of Radina is in turn connected to engagement member 2 of Radina, and thus cylinder 7a of Radina is configured to transfer at least a portion of the force to engagement member 2 of Radina to increase the amount of force the engagement members 1, 2 of Radina imparts onto the patient).
Regarding claim 37, Radina in view of Schule further in view of Schuele ‘765 discloses the invention as discussed in claim 27. Radina in view of Schule further in view of Schuele ‘765 further discloses an adjustment feature (5 of Radina) configured to adjust the relative position of the first and second frame portions to overcome the force applied to the stabilization assembly (1, 1a, 2, 2a of Radina) by the tensioning feature (7, 18, 19, 20, 21, 22 of Radina) (see Annotated Fig. 2 of Radina and Figs. 1-2 of Radina; connecting means 5 of Radina is an adjustment feature as according to applicant’s specification in paragraph [00048] on page 6, the adjustment feature includes an actuator to adjust the relative spacing between frame portions, and connecting means 5 of Radina comprises a trapeziform translation guide 12 of Radina which allows a translational movement between the first and second frame portions, and the connecting means 5 of Radina comprises lever 22 of Radina which functions the same as lever 16 of Radina and thus is an actuator and thus the trapeziform guide 12 of Radina
can overcome the force applied to the stabilization assembly 1, 1a, 2, 2a of Radina by the force applicator 7 of Radina which is part of the tensioning feature, as the trapeziform translation guide 12 of Radina allows translational movement between the first and second frame portions which changes the amount of force that will be imparted on a patient as the frames can move closer or further apart).
Regarding claim 38, Radina in view of Schule further in view of Schuele ‘765 discloses the invention as discussed in claim 27. Radina in view of Schule further in view of Schuele ‘765 further discloses wherein the tensioning feature (7, 18, 19, 20, 21, 22 of Radina) comprises a torsion rod (8 of Radina) (see Fig. 1 of Radina; the gripping means 8 of Radina of force applicator 7 of Radina is a torsion rod as it is a straight piece of material that is to be rotated or turned by a surgeon), wherein a torque on the torsion rod (8 of Radina) transfers a force to the elongated member (7a of Radina), and wherein the elongated member (7a of Radina) transfers at least a portion of the force to the stabilization assembly (1, 1a, 2, 2a of Radina) to increase the amount of force the stabilization assembly (1, 1a, 2, 2a of Radina) imparts onto the patient (see Figs. 1-2 of Radina; when gripping means 8 of Radina is turned or rotated by the surgeon, a force is transferred to cylinder 7a of Radina and the cylinder 7a transfers at least a portion of the force to the engagement member 2 of Radina to increase the amount of force the stabilization assembly imparts onto the patient, see Col. 8 lines 50-60 of Radina).
Regarding claim 39, Radina in view of Schule further in view of Schuele ‘765 discloses the invention as discussed in claim 27. Radina in view of Schule further in view of Schuele ‘765 further discloses wherein the tensioning feature (7, 18, 19, 20, 21, 22 of Radina) is configured to apply the amount of force to the stabilization assembly (1,1a,2,2a of Radina) via a twisting action (see Figs. 1-2 and Col. 8 lines 50-60 of Radina; the force applicator 7 of Radina which is part of the tensioning feature is configured to apply the amount of force to engagement members 1,2 of Radina via a twisting action as force applicator 7 of Radina includes a gripping means 8 of Radina and gripping means 9 of Radina that are both rotated or twisted in order to apply force to the stabilization assembly).
Regarding claim 40, Radina in view of Schule further in view of Schuele ‘765 discloses the invention as discussed in claim 27. Radina in view of Schule further in view of Schuele ‘765 further discloses wherein the actuator (7, 20, 21 of Radina) is configured to provide pre-tension to the stabilization assembly (1, 1a, 2, 2a of Radina) (see Figs. 1-2 of Radina; the force applicator 7 of Radina is configured to provide pre-tension to the stabilization assembly 1, 1a, 2, 2a of Radina as the first gripping means 8 of Radina of the force applicator 7 of Radina is first rotated to the appropriate amount of force wanted for the patient’s head and then the surgeon grips the second gripping means 9 of Radina of the force indicator 7 of Radina to fix the second engagement member 2 of Radina to the second frame section 4 of Radina and thus provides pre-tension to the second engagement member 2 of Radina as the force indicator 7 of Radina is first adjusted to the amount of tension wanted and then fixed to the second engagement member 2 of Radina).
Regarding claim 41, Radina in view of Schule further in view of Schuele ‘765 discloses the invention as discussed in claim 27. Radina in view of Schule further in view of Schuele ‘765 further discloses wherein the stabilization assembly (1, 1a, 2, 2a of Radina) defines a proximal end and a distal end, wherein the distal end is configured to receive the stabilization feature (1a, 2a of Radina) (the engagement member 1 of Radina defines a proximal end and a distal end where the distal end is the end that is attached to pin 1a of Radina and the proximal end is the opposite end, and the engagement member 2 of Radina defines a proximal end and a distal end where the distal end is the end attached to pin 2a of Radina and the proximal end is the opposite end), the stabilization assembly further defines an axis extending from the proximal end to the distal end, wherein the actuator (7, 20, 21 of Radina) positioned at the second location is located along a different axis from the axis defined by the stabilization assembly (see Annotated Fig. 2 (2) of Radina; the dotted horizontal line of engagement members 1, 2 of Radina in the annotated Fig. 2 (2) of Radina shows axes extending from the proximal end to the distal end of each of the engagement members 1, 2 of Radina, and the levers 20, 21 of Radina both define axes that are different from the axes defined by the engagement members 1, 2 of Radina, as seen in Annotated Fig. 2 (2) of Radina).
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Annotated Fig. 2 (2) of Radina.
Claim(s) 29-30 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radina in view of Schuele ‘937 further in view of Moffatt.
Regarding claim 29, Radina in view of Schuele ‘937 discloses the invention as discussed in claim 27. Radina in view of Schuele ‘937 further discloses the actuator (7, 20, 21 of Radina) having a body (see Fig. 1 of Radina; the entire frame of force applicator 7 of Radina is a body), the actuator (7, 20, 21 of Radina) configured to transmit rotary motion to the body (see Fig. 1 of Radina; force applicator 7 of Radina includes gripping means 8 of Radina which is rotated or turned and thus the gripping means 8 of Radina is configured to transmit rotary motion to cylinder 7a of Rainda which is part of the body of the force applicator 7 of Radina).
Radina in view of Schuele ‘937 is silent on the body having a cylindrical portion including threading, the threading being configured to engage threading of the elongated member to move the elongated member relative to the body.
However, Moffatt teaches an analogous device for stabilizing a patient (see Fig. 4, Abstract; head fixation device 50 clamps a patient’s head to stabilize a patient), and teaches an analogous actuator (66) having a body (see Figs. 4 and 6-7; the entire frame of hand wheel 66 is the body), the body having a cylindrical portion (66A) including threading, the threading being configured to engage threading of the elongated member (65) to move the elongated member (65) relative to the body (see Figs. 5-8; cylindrical insert portion 66A comprises receptacle 66C, as seen in Fig. 7, which is a splined recess, see Col. 15 lines 17-25, and thus the splined recess is interpreted to be threading as a splined recess means there are a series of ridges which form threadings, and screw 65 comprises splined heads, as best seen in Fig. 5, which are interpreted to be threadings, as the definition of a thread is “a continuous raised line, such as the one that goes around the outside of a screw or bolt or the inside of a hole,” and the definition of spline is “any series of uniformly raised spaced ridges on a shaft, parallel to its axis and fitting inside corresponding grooves in the hub of a gear, etc., to transmit torque,” and thus the splined recess of hand wheel 66 and the splined heads of screw 65 are engaged together to move screw 65 relative to the body of hand wheel 66, so that screw 65 is able to be rotated, see Col. 15 lines 17-31, Col. 13 lines 16-20, and Col. 14 lines 8-12), providing splined bodies that are able to provide more control and uniform load distribution which allows for more reliable load transmission and faster speeds without the risk for misalignment of parts.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the body of the actuator (7 of Radina) in the device of Radina in view of Schuele ‘937 to be cylindrical with threadings as taught by Moffatt and to have modified the outside of the elongate member (7a of Radina) in the device of Radina in view of Schuele ‘937 to have complementary threadings as taught by Moffatt to have provided an improved head stabilization device that provides splined bodies that are able to provide more control and uniform load distribution which allows for more reliable load transmission and faster speeds without the risk for misalignment of parts.
Regarding claim 30, Radina in view of Schuele ‘937 discloses the invention as discussed in claim 27. Radina in view of Schuele ‘937 further discloses the actuator (7,20,21 of Radina) having a body (see Fig. 1 of Radina; lever 21 has a lever 22 which is a body), the actuator (7, 20, 21 of Radina) configured to transmit rotary motion to the body (see Fig. 1 of Radina; the lever 21 of Radina is configured to transmit rotary motion to lever 22, as the lever 21 is connected to lever 22 via push bar 19, and when lever 21 is turned, the lever 22 is moved accordingly).
the force applicator 7 of Radina includes first gripping means 8 of Radina, which is rotated or turned and thus the first gripping means 8 of Radina of the force applicator 7 of Radina is configured to transmit rotary motion to cylinder 7a of Radina which is part of the body of the force applicator 7).
Radina in view of Schuele ‘937 is silent on the body having a cylindrical portion including thread, the threading being configured to engage threading of the second frame portion to move the second frame portion and the elongated member relative to the first frame portion.
However, Moffatt teaches an analogous device for stabilizing a patient (see Fig. 4 and Abstract; head fixation device 50 clamps a patient’s head to stabilize a patient), and teaches an analogous actuator (66) having a body (see Figs. 4 and 6-7; the entire frame of hand wheel 66 is the body), the body having a cylindrical portion (66A) including threading, the threading being configured to engage threading of the second frame portion to move the second frame portion and the elongated member (65) relative to the first frame portion (see Figs. 5-8; cylindrical insert portion 66A comprises receptacle 66C, as seen in Fig. 7, which is a splined recess, see Col. 15 lines 17-25, and thus the splined recess is interpreted as threading, as a splined recess means there are a series of ridges which are threadings, see definition of thread: “a continuous raised line, such as one that goes around the outside of a screw or bolt or the inside of a hole,” and definition of spline: “any series of uniformly spaced ridges on a shaft, parallel to its axis and fitting inside corresponding grooves in the hub of a gear, etc., to transmit torque,” and thus the threading or splined recess of the cylindrical insert portion 66A is configured to engage threading of the second frame portion as the second frame portion includes screw 65 which comprises splined heads, as best seen in Fig. 5, which are interpreted as threading, and thus the second frame portion and screw 65 are moved relative to the first frame portion as the second frame portion comprises slide element 72, see Col. 15 lines 17-31, Col. 13 lines 5-20, and Col. 14 lines 8-12), providing splined bodies that are able to provide more control and uniform load distribution which allows for more reliable load transmission and faster speeds without the risk for misalignment of parts.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the body (22 of Radina) and the push bar (19 of Radina) in the device of Radina in view of Schuele ‘937 to have complementary threadings to move the second frame portion and the elongated member relative to the first frame portion as taught by Moffatt to have provided an improved head stabilization device that provides splined bodies that are able to provide more control and uniform load distribution which allows for more reliable load transmission and faster speeds without the risk for misalignment of parts.
Regarding claim 33, Radina in view of Schuele ‘937 discloses the invention as discussed in claim 32.
Radina in view of Schuele ‘937 is silent on the force indication feature including a plurality of indicators, wherein the elongated member is movable relative to the plurality of indicators to indicate the amount of force the stabilization assembly is configured to impart onto the patient.
However, Moffatt teaches an analogous device for stabilizing a patient (see Fig. 4 and Abstract; head fixation device 50 clamps a patient’s head to stabilize a patient), and teaches an analogous force indication feature (66V, 66Y) including a plurality of indicators 66Y) (see Figs. 6-7 and Col. 15 lines 1-5; windows 66Y are arranged angularly around the hand wheel 66 to indicate the pressure by gauge 66V and thus are a plurality of indicators), wherein the elongated member (65) is movable relative to the plurality of indicators (66Y) to indicate the amount of force the stabilization assembly is configured to impart onto the patient (see Figs. 4, 6-9; screw 65 is movable relative to windows 66Y to indicate the amount of force the stabilization assembly imparts onto the patient, see Col. 14 lines 52-54 and Col. 15 lines 1-8, as screw 65 is rotated and thus is moved, see Col. 12 lines 46-52 and Col. 13 lines 36-42, and thus the windows 66Y visually indicate the amount of force the stabilization assembly imparts onto the patient), providing a visual indication of pressure applied to a user making it easier for a surgeon to know how much pressure is being applied to a patient making it easier to adjust the pressure.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the force indication feature (11 of Radina) of Radina in view of Schuele ‘937 with a plurality of indicators (66Y) and a pressure gauge (66V) as taught by Moffatt to have provided an improved device for stabilizing a patient that provides a better visual indication of pressure applied to a user making it easier for a surgeon to know how much pressure is being applied to a patient and making it easier to adjust the pressure.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 26-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,343,278 B2 in view of Schuele ‘937.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claim 1 of Patent ‘278 recites the limitations of a device for stabilizing a patient comprising a frame assembly having a first frame portion that defines a lateral portion and an upright portion, wherein the upright portion includes a receiving portion, and a stabilization assembly configured to be received by the receiving portion of the upright portion of the first frame portion.
The Patent ‘278 fails to recite a second frame portion, the first and second frame portions are selectively movable relative to one another to adjust a space between the first and second frame portions, wherein each of the first and second frame portions comprises an upright portion and a lateral portion, wherein the lateral portions define a length and the lateral portions have a cylindrical shape along at least a portion of the length; and an interface configured to attach a skull clamp, directly or indirectly, with a patient support structure, wherein the interface is positioned along the length defined by the lateral portions of the frame assembly and oriented transverse to a longitudinal axis defined by the length of the lateral portions of the frame assembly.
However, Schuele ‘937 teaches an analogous device for stabilizing a patient (see Fig. 1 and Abstract and [0002]), and a second frame portion (30), the first and second frame portions are selectively movable relative to one another to adjust a space between the first and second frame portions (see [0022] which discusses how the first arm 20 and second arm 30 are selectively movable relative to one another to adjust a space between them, see Figs. 1-2), wherein each of the first and second frame portions comprises an upright portion (21, 31) and a lateral portion (22, 32) (see Figs. 1-2 and [0019]-[0020]; the first arm 20 has an upright portion 21 and lateral portion 22, and second arm 30 has an upright portion 31 and lateral portion 32), wherein the upright portions (21, 31) each are configured to receive a stabilization assembly (12, 14) (see Figs. 1-2 and [0019]-[0020]; the upright portions 21 and 31 each receive a first pin assembly 12 and a second pin assembly 14, respectively), and wherein the lateral portions (22, 32) define a length and the lateral portions (22, 32) have a cylindrical shape along at least a portion of the length (see Figs. 1-2; the lateral portions 22, 32 each define a length horizontally, and the arms 20, 30 may have a cylindrical shape, see [0040], and thus the lateral portions 22, 32 may have a cylindrical shape along at least a portion of the length); and an interface (40, 42) configured to attach a skull clamp (10), directly or indirectly, with a patient support structure (see Figs. 1-4 and [0024]; starburst interfaces 40,42 are configured to attach skull clamp 10, directly or indirectly, with an operating table which is a patient support structure), wherein the interface (40, 42) is positioned along the length defined by the lateral portions (22, 32) of the frame assembly (20,30) and oriented transverse to a longitudinal axis defined by the length of the lateral portions (22, 32) of the frame assembly (20, 30) (see Figs. 1-4 and [0024]; the starburst interfaces 40,42 are positioned along the length defined by the lateral portions 22,32, and the starburst interfaces 40,42 are oriented transverse to a longitudinal axis defined by the length of the lateral portions 22, 32, see Annotated Fig. 1 of Schuele '397 that has the longitudinal axis defined by the length of the lateral portions 22, 32 labeled), providing to adjust the space between the frame portions to better fit various users head sizes and to allow for easy attachment to a surgical table.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device for stabilizing a patient of Patent ‘278 to have a second frame portion, and the first and second frame portions are selectively movable relative to one another to adjust a space between the first and second frame portions, wherein each of the first and second frame portions comprises an upright portion and a lateral portion, wherein the lateral portions define a length and the lateral portions have a cylindrical shape along at least a portion of the length, and to have modified the device for stabilizing a patient of Patent ‘278 to have an interface configured to attach a skull clamp, directly or indirectly, with a patient support structure, wherein the interface is positioned along the length defined by the lateral portions of the frame assembly and oriented transverse to a longitudinal axis defined by the length of the lateral portions of the frame assembly to have provided an improved device for stabilizing a patient that adjusts the space between the frame portions to better fit various users head sizes and to allow for easy attachment to a surgical table.
With respect to claim 27 of the instant application, all limitations are found in claim 1 of Patent ‘278.
With respect to claim 28 of the instant application, all limitations are found in claim 7 of Patent ‘278.
With respect to claim 29 of the instant application, all limitations are found in claim 8 of Patent ‘278.
With respect to claim 30 of the instant application, all limitations are found in claim 9 of Patent ‘278.
With respect to claim 31 of the instant application, all limitations are found in claim 10 of Patent ‘278.
With respect to claim 32 of the instant application, all limitations are found in claim 5 of Patent ‘278.
With respect to claim 33 of the instant application, all limitations are found in claim 6 of Patent ‘278.
With respect to claim 34 of the instant application, all limitations are found in claim 3 of Patent ‘278.
With respect to claim 35 of the instant application, all limitations are found in claim 4 of Patent ‘278.
With respect to claim 36 of the instant application, all limitations are found in claim 1 of Patent ‘278.
With respect to claim 37 of the instant application, all limitations are found in claim 11 of Patent ‘278.
With respect to claim 38 of the instant application, all limitations are found in claim 12 of Patent ‘278.
With respect to claim 39 of the instant application, all limitations are found in claim 13 of Patent ‘278.
With respect to claim 40 of the instant application, all limitations are found in claim 14 of Patent ‘278.
With respect to claim 41 of the instant application, all limitations are found in claim 1 of Patent ‘278.
With respect to claim 42 of the instant application, all limitations are found in claim 1 of Patent ‘278 in view of Schuele ‘937.
The Patent ‘278 in view of Schuele ‘937 is silent on a first body having a first end and a second end, wherein the first end is configured to connect with the stabilization assembly of the stabilization device, and an actuator, directly or indirectly connectable with the first body, wherein the actuator is configured to cause a torque to be applied on the first body, wherein an increase in the torque on the first body increases a tension within the first body, wherein the first body applies an increase in force to the stabilization assembly in response to the increase in tension within the first body.
However, Moffatt teaches an analogous head stabilization device (see Fig. 4), and (a) a first body (65 of Moffatt) having a first end and a second end (see Figs. 4-5 of Moffatt; screw 65 of Moffatt is a first body as it is a physical structure and screw 65 of Moffatt has a first end which is the end on the left side in Fig. 4 of Moffatt and a second end which is the end that is on the right side in Fig. 4 of Moffatt and attached to hand wheel 66 of Moffat), wherein the first end is configured to connect with the stabilization assembly (51, 53, 55, 56 of Moffatt) of the stabilization device (50 of Moffatt) (see Fig. 4 of Moffatt; the first end which is the end on the left side in Fig. 4 of Moffatt of screw 65 of Moffatt is configured to connect with leg 53 and clamp member 56 of Moffatt which are part of the stabilization assembly of head fixation device 50 of Moffat); and
(b) an actuator (66W of Moffatt), directly or indirectly connectable with the first body (65 of Moffatt) (see Figs. 4-9 of Moffatt hand wheel portion 66W of Moffatt is an actuator as it is a manually graspable hand wheel, and hand wheel portion 66W of Moffatt is indirectly connectable with screw 65 of Moffatt as seen in Fig. 8 of Moffatt), wherein the actuator (66W of Moffatt) is configured to cause a torque to be applied on the first body (65 of Moffatt) (see Fig. 4 of Moffatt; hand wheel portion 66W of Moffatt is configured to cause a torque to be applied to screw 65 of Moffatt as hand wheel portion 66W of Moffatt is rotated which causes screw 65 of Moffatt to be rotated; see Col. 14 lines 32-36 of Moffatt), wherein an increase in the torque on the first body (65 of Moffatt) increases a tension within the first body (65 of Moffatt) (see Fig. 4 of Moffatt; an increase in the torque on screw 65 of Moffatt via hand wheel portion 66W of Moffatt increases a tension within the screw 65 of Moffatt as the screw acts to pull on nut component 75 of Moffatt to pull the clamp into tension on the head of the patient), wherein the first body (65 of Moffatt) applies an increase in force to the stabilization assembly (51, 53, 55, 56 of Moffatt) in response to the increase in tension within the first body (65 of Moffatt) (see Fig. 4 of Moffatt and Col. 14 lines 32-36 of Moffatt; the screw 65 of Moffatt applies an increase in force to the stabilization assembly 51, 53, 55, 56 of Moffat in response to the increase in tension within the screw 65 of Moffatt as the screw 65 of Moffatt is rotated to increase the pressure on the skull of a user via stabilization assembly 51, 53, 55, 56 of Moffatt), providing an actuator that is easy to use so a user is able to easily adjust the amount of force imparted on the patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the head stabilization device of Patent ‘278 in view of Schuele ‘937 to comprise a first body having a first end and a second end, wherein the first end is configured to connect with the stabilization assembly of the stabilization device, and an actuator, directly or indirectly connectable with the first body, wherein the actuator is configured to cause a torque to be applied on the first body, wherein an increase in the torque on the first body increases a tension within the first body, wherein the first body applies an increase in force to the stabilization assembly in response to the increase in tension within the first body as taught by Moffatt to have provided an improved head stabilization device that provides an actuator that is easy to use so a user is able to easily adjust the amount of force imparted on the patient.
With respect to claim 43 of the instant application, all limitations are found in claim 1 of Patent ‘278 in view of Schuele ‘937 further in view of Moffatt.
The Patent ‘278 in view of Scheuele ‘937 further in view of Moffat further teaches wherein the dimensions of the first body (65 of Moffatt) remain constant when the torque is applied on the first body (65 of Moffatt) and when the tension increases within the first body (65 of Moffatt) (see Fig. 4; the dimensions of screw 65 of Moffatt remain constant when the torque is applied on the screw 65 of Moffatt and when the tension increases within screw 65 of Moffatt), providing a durable structural body.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimensions of the first body of copending application ‘029 in view of Moffatt further in view of Schule to remain constant when torque is applied on the first body and when tension increases within the first body as taught by Moffatt to have provided an improved head stabilization device that provides a durable structural body.
With respect to claim 44 of the instant application, all limitations are found in claim 1 of Patent ‘278 in view of Schuele ‘937 further in view of Moffatt.
Patent ‘278 in view of Schuele ‘937 further in view of Moffatt further teaches a second body (66A+66B+66M of Moffatt) connected with the first body (65 of Moffatt) at the second end in a keyed manner such that the first body (65 of Moffatt) and the second body (66A+66B+66M of Moffatt) are prevented from rotating relative to one another (see Figs. 4-9 of Moffatt; cylindrical insert portion 66A + 66B + collar 66M of Moffatt make up a second body and is connected to screw 65 of Moffatt at the second end, as the second end is the end of screw 65 of Moffatt that is on the right side in Fig. 4 of Moffatt and attached to hand wheel 66 of Moffatt, and is connected in a keyed manner as cylindrical insert portion 66A of Moffatt comprises receptacle 66C of Moffatt as seen in Fig. 7 of Moffatt which is a splined recess, see Col. 15 lines 17-25 of Moffatt, and thus the splined recess engages with the splined heads of screw 65 of Moffatt to be connected in a keyed manner such that they are prevented from rotating relative to one another, see Col. 15 lines 17-31, Col. 13 lines 16-20, and Col. 14 lines 8-12 of Moffatt), wherein the second body (66A+66B+66M of Moffatt) and the first body (65 of Moffatt) are oriented substantially perpendicular to one another (see Annotated Fig. 8 of Moffatt; the collar 66M of the second body of Moffatt is oriented perpendicular to the screw 65 of Moffatt, as seen in Annotated Fig. 8 of Moffatt via the vertical and horizontal lines), providing an actuator that is easy to use so a user is able to easily adjust the amount of force imparted on the patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the head stabilization device of copending application ‘029 in view of Moffatt further in view of Schule to comprise a second body connecting with the first body at the second end in a keyed manner such that the first body and the second body are prevented from rotating relative to one another, wherein the second body and the first body are oriented substantially perpendicular to one another as taught by Moffatt to have provided an improved head stabilization device that has an actuator that is easy to use so a user is able to easily adjust the amount of force imparted on the patient.
With respect to claim 45 of the instant application, all limitations are found in claim 1 of Patent ‘278 in view of Schuele ‘937 further in view of Moffatt.
Patent ‘278 in view of Schuele ‘937 further in view of Moffatt further teaches wherein the actuator (66W of Moffatt) is directly or indirectly connectable with the second body (66A+66B+66M of Moffatt) (see Figs. 6-9 of Moffatt; the hand wheel portion 66W of Moffatt is directly connectable with the cylindrical portion 66A+66B+collar 66M of Moffatt), wherein the actuator (66W of Moffatt) is configured to cause the torque to be applied on the first body by causing the torque to be applied on the second body (66A+66B+66M of Moffatt) and transferred to the first body (65 of Moffatt) such that the tension within the first body (65 of Moffatt) increases (see Figs. 4-9 of Moffatt and Col. 14 lines 32-36 of Moffatt; the hand wheel portion 66W of Moffatt is configured to cause the torque to be applied on the screw 65 of Moffatt by causing the torque to be applied to cylindrical portion 66A+66B+collar 66M of Moffatt as these portions are all connected to each other and then transferred to screw 65 of Moffatt such that the tension within the screw 65 of Moffatt increases), providing an actuator that is easy to use so a user is able to easily adjust the amount of force imparted on the patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the head stabilization device of copending application ‘029 in view of Moffatt further in view of Schule such that the actuator is directly or indirectly connectable with the second body, wherein the actuator is configured to cause the torque to be applied on the first body by causing the torque to be applied on the second body and transferred to the first body such that the tension within the first body increases as taught by Moffatt to have provided an improved head stabilization device that has an actuator that is easy to use so a user is able to easily adjust the amount of force imparted on the patient.
With respect to claim 46 of the instant application, all limitations are found in claim 1 of Patent ‘278 in view of Schuele ‘937 further in view of Moffatt.
Patent ‘278 in view of Schuele ‘937 further in view of Moffatt further teaches wherein the dimensions of the second body (66A+66B+66M of Moffatt) remain constant when the torque is applied on the second body (66A+66B+66M of Moffatt) causing the increase in tension within the first body (65 of Moffatt) (see Figs. 4-9 of Moffatt; the dimensions of cylindrical portion 66A+66B+collar 66M of Moffatt remains constant when torque is applied to it causing the increase in tension within screw 65 of Moffatt), providing a durable structural body.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimensions of the second body of copending application ‘029 in view of Moffatt further in view of Schule to remain constant when torque is applied n the second body causing the increase in tension within the first body to have provided an improved head stabilization device that provides a durable structural body.
This is a nonstatutory double patenting rejection.
Conclusion
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/ROBIN HAN/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
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