DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 12 is objected to because of the following informalities: In line 4, claim 12 recites, “on a second side of the patient’s with”. It appears it should recite –on a second side of the patient’s head--. 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 1-5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the range" in line 20. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, it will be interpreted as --a range--.
Claim 1 recites the limitation "the difference" in 21. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, it will be interpreted as –a difference--.
As claims 2-5 depend from claim 1, they are rejected for at least the same reason as claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-11 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites at lines 10-11, “wherein a first number of pins on a first side of the patient’s head is more or less than a second number of pins on a second side of the patient’s head” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite -- wherein a first number of pins on a first side of the patient’s head is configured to be more or less than a second number of pins configured to be on a second side of the patient’s head--.
As claims 2-5 depend from claim 1, they are rejected for at least the same reasons as claim 1.
Claim 6 recites at lines 11-14, “wherein a first pin of the plurality of pins located on the first side of the patient’s head comprises a first pin angle, and wherein a second pin and a third pin of the plurality of pins located on the second side of the patient’s head each comprise a second pin angle” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite --wherein a first pin of the plurality of pins configured to be located on the first side of the patient’s head comprises a first pin angle, and wherein a second pin and a third pin of the plurality of pins located configured to be located on the second side of the patient’s head each comprise a second pin angle--.
As claims 7-10 depend from claim 6, they are rejected for at least the same reasons as claim 6.
Claim 11 recites at lines 10-12, “wherein a first number of pins on a first side of the patient’s head is more or less than a second number of pins on a second side of the patient’s head” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite -- wherein a first number of pins configured to be located on a first side of the patient’s head is more or less than a second number of pins configured to be located on a second side of the patient’s head --.
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 1 is rejected on the ground of nonstatutory double patenting as being unpatentable
over claim 1 of U.S. Patent No. 12,090,000 B2 (reference patent). Although the claims at issue are
not identical, they are not patentably distinct from each other because the application claims are a narrower recitation of the invention that that of the patented application.
Claim 1 of the instant application recites: A skull clamp for stabilizing a head of a patient during a medical procedure, wherein the skull clamp comprises: (a) a first arm, wherein the first arm comprises a first upright portion connected with a first lateral portion; (b) a second arm, wherein the second arm comprises a second upright portion connected with a second lateral portion; (c) at least two pin assemblies connectable with the first or second arm; and (d) a plurality of pins configured to engage a skull of the patient to stabilize the head of the patient, wherein each of the pin assemblies has at least one pin of the plurality of pins, wherein a first number of pins on a first side of the patient's head is more or less than a second number of pins on a second side of the patient's head that is opposite to the first side of the patient's head; wherein a first pin of the plurality of pins located on the first side of the patient's head comprises a first pin angle, and wherein a second pin and a third pin of the plurality of pins located on the second side of the patient's head each comprise a second pin angle, wherein the first pin angle and the second pin angle are defined by an intersection of a longitudinal axis of the respective pins with an axis of the respective pins extending from a distal tip of the respective pins proximally along a distal tapered region of the respective pins, wherein the second pin angle is smaller than the first pin angle, and wherein the first pin angle and the second pin angle are each within the range of 10 degrees to 30 degrees with the difference between the first pin angle and the second pin angle is at least 1 degree.
Claim 1 of the reference patent recites: a skull clamp for stabilizing a head of a patient during a medical procedure, wherein the skull clamp comprises: (a) a first arm, wherein the first arm comprises a first upright portion connected with a first lateral portion; (b) a second arm, wherein the second arm comprises a second upright portion connected with a second lateral portion; (c) at least two pin assemblies connectable with the first or second arm; and (d) a plurality of pins configured to engage a skull of the patient to stabilize the head of the patient, wherein each of the pin assemblies has at least one pin of the plurality of pins, wherein a first number of pins on a first side of the patient's head is more or less than a second number of pins on a second side of the patient's head that is opposite to the first side of the patient's head; wherein a first pin of the plurality of pins located on the first side of the patient's head comprises a first pin angle, and wherein a second pin and a third pin of the plurality of pins located on the second side of the patient's head each comprise a second pin angle, wherein the first pin angle and the second pin angle are defined by an intersection of a longitudinal axis of the respective pins with an axis of the respective pins extending from a distal tip of the respective pins proximally along the respective pins, wherein the first pin angle and the second pin angle differ.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 1 of the current application and claim 1 of U.S. Patent No. (12,090,000 B2) lies in the fact that the claims of the instant invention include many more elements and is thus much more specific. Thus, the invention of claim 1 of instant invention is in effect a “species” of the “generic” invention of U.S. Patent No. (12,090,000 B2) claim 1. It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the of U.S. Patent No. (12,090,000 B2) is anticipated by claim 1 of the instant invention, it is not patentably distinct from claim 1 of the instant invention.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable
over claim 13 of U.S. Patent No. 12,090,000 B2 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are a narrower recitation of the invention that that of the patented application.
Claim 6 of the instant application recites: A skull clamp for stabilizing a head of a patient during a medical procedure, wherein the skull clamp comprises: (a) a U-shape having a first upright portion positionable on a first side of the patient's head, and a second upright portion positionable on a second side of the patient's head that is opposite to the first side of the patient's head; (b) a first pin assembly connectable with the first upright portion; (c) a second pin assembly connectable with the second upright portion; and (d) a plurality of pins configured to engage a skull of the patient to stabilize the head of the patient, wherein each of the pin assemblies has at least one pin of the plurality of pins, wherein a first number of pins on the first side of the patient's head is more or less than a second number of pins on the second side of the patient's head, wherein a first pin of the plurality of pins located on the first side of the patient's head comprises a first pin angle, and wherein a second pin and a third pin of the plurality of pins located on the second side of the patient's head each comprise a second pin angle, wherein the first pin angle and the second pin angle are defined by an intersection of a longitudinal axis of the respective pins with an axis of the respective pins extending from a distal tip of the respective pins proximally along a distal tapered region of the respective pins, wherein the second pin angle is smaller than the first pin angle.
Claim 13 of the reference patent recites: A skull clamp for stabilizing a head of a patient during a medical procedure, wherein the skull clamp comprises: (a) a first arm, wherein the first arm comprises a first upright portion connected with a first lateral portion; (b) a second arm, wherein the second arm comprises a second upright portion connected with a second lateral portion; (c) at least two pin assemblies connectable with the first or second arm; and (d) a plurality of pins configured to engage a skull of the patient to stabilize the head of the patient, wherein each of the pin assemblies has at least one pin of the plurality of pins, wherein a first number of pins on a first side of the patient's head is more or less than a second number of pins on a second side of the patient's head that is opposite to the first side of the patient's head, and wherein a first pin on the first side of the patient's head comprises a first tapered portion having a first conical shape with a first radius, and a second pin and a third pin on the second side of the patient's head each comprise a second tapered portion having a second conical shape with a second radius, wherein the second radius is smaller than the first radius, and wherein a first contact area of the second pin and the third pin is less than a second contact area of the first pin when the skull clamp is used to stabilize the head of the patient thereby reducing a disparity in a pinning pressure among the first pin, the second pin, and the third pin.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 6 of the current application and claim 13 of U.S. Patent No. (12,090,000 B2) lies in the fact that the claims of the instant invention include many more elements and is thus much more specific. Thus, the invention of claim 6 of instant invention is in effect a “species” of the “generic” invention of U.S. Patent No. (12,090,000 B2) claim 13. It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 13 of the of U.S. Patent No. (12,090,000 B2) is anticipated by claim 6 of the instant invention, it is not patentably distinct from claim 6 of the instant invention.
3. Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable
over claim 15 of U.S. Patent No. 12,090,000 B2 (reference patent). Although the conflicting claims are not identical, they are not patentably distinct from each other because the application claims are a broader recitation of the invention than that of the patented application.
Claim 11 of the instant application recites: A skull clamp for stabilizing a head of a patient
during a medical procedure, wherein the skull clamp comprises: (a) a first arm, wherein the first arm comprises a first upright portion connected with a first lateral portion; (b) a second arm, wherein the second arm comprises a second upright portion connected with a second lateral portion; (c) at least two pin assemblies connectable with the first or second arm; and (d) a plurality of pins configured to engage a skull of the patient to stabilize the head of the patient, wherein each of the pin assemblies has at least one pin of the plurality of pins, wherein a first number of pins on a first side of the patient's head is more or less than a second number of pins on a second side of the patient's head that is opposite to the first side of the patient's head; wherein a first pin of the plurality of pins located on the first side of the patient's head comprises a first circular area in cross section at a first penetration depth, and wherein each of the second and third pins comprise a second circular area in cross section at the first penetration depth, wherein the second circular area is smaller than the first circular area.
Claim 15 of the reference patent recites: A skull clamp for stabilizing a head of a patient during a medical procedure, wherein the skull clamp comprises: (a) a first arm, wherein the first arm comprises a first upright portion connected with a first lateral portion; (b) a second arm, wherein the second arm comprises a second upright portion connected with a second lateral portion; (c) at least two pin assemblies connectable with the first or second arm; and (d) a plurality of pins configured to engage a skull of the patient to stabilize the head of the patient, wherein each of the pin assemblies has at least one pin of the plurality of pins, wherein a first number of pins on a first side of the patient's head is more or less than a second number of pins on a second side of the patient's head that is opposite to the first side of the patient's head, and wherein a first pin on the first side of the patient's head comprises a first tapered portion having a first conical shape with a first radius, and a second pin and a third pin on the second side of the patient's head each comprise a second tapered portion having a second conical shape with a second radius, wherein the second radius is smaller than the first radius, and wherein a first contact area of the second pin and the third pin is less than a second contact area of the first pin when the skull clamp is used to stabilize the head of the patient thereby reducing a disparity in a pinning pressure among the first pin, the second pin, and the third pin, wherein the first pin comprises a first circular area in cross section at a first penetration depth, and wherein each of the second and third pins comprise a second circular area in cross section at the first penetration depth, wherein the second circular area is smaller than the first circular area.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 11 of the current application and claim 15 of U.S. Patent No. (12,090,000 B2) lies in the fact that the patented claims include many more elements and is thus much more specific. Thus, the invention of claim 11 of U.S. Patent No. (12,090,000 B2) is in effect a “species” of the “generic” invention of current application claim 15. It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 11 of the current application is anticipated by claim 15 of U.S. Patent No. (12,090,000 B2) it is not patentably distinct from claim 1 of patent ('546).
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable
over claim 1 of U.S. Patent No. 12,090,000 (reference patent). Although the conflicting claims are not identical, they are not patentably distinct from each other because the application claims are a broader recitation of the invention than that of the patented application.
Claim 12 of the instant application recites: A method of using a skull clamp to stabilize a head of a patient comprising: engaging a first pin located on a first side of the patient's head with the head of the patient, wherein the first pin comprises a first pin angle; and engaging a second pin and a third pin on a second side of the patient's with the head of the patient, wherein the second side of the patient's head is opposite to the first side of the patient's head, wherein the second pin and the third pin each comprise a second pin angle, wherein the first pin angle and the second pin angle are defined by an intersection of a longitudinal axis of the respective pins with an axis of the respective pins extending from a distal tip of the respective pins proximally along a portion of the respective pins, wherein the second pin angle is smaller than the first pin angle.
Claim 1 of U.S. Patent No. (12,090,000 B2) recites: a skull clamp for stabilizing a head of a patient during a medical procedure, wherein the skull clamp comprises: (a) a first arm, wherein the first arm comprises a first upright portion connected with a first lateral portion; (b) a second arm, wherein the second arm comprises a second upright portion connected with a second lateral portion; (c) at least two pin assemblies connectable with the first or second arm; and (d) a plurality of pins configured to engage a skull of the patient to stabilize the head of the patient, wherein each of the pin assemblies has at least one pin of the plurality of pins, wherein a first number of pins on a first side of the patient's head is more or less than a second number of pins on a second side of the patient's head that is opposite to the first side of the patient's head; wherein a first pin of the plurality of pins located on the first side of the patient's head comprises a first pin angle, and wherein a second pin and a third pin of the plurality of pins located on the second side of the patient's head each comprise a second pin angle, wherein the first pin angle and the second pin angle are defined by an intersection of a longitudinal axis of the respective pins with an axis of the respective pins extending from a distal tip of the respective pins proximally along the respective pins, wherein the first pin angle and the second pin angle differ.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 12 of the current application and claim 1 of U.S. Patent No. (12,090,000 B2) lies in the fact that the patented claims include many more elements and is thus much more specific. Thus, the invention of claim 1 of U.S. Patent No. (12,090,000 B2) is in effect a “species” of the “generic” invention of current application claim 12. It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 12 of the current application is anticipated by claim 1 of U.S. Patent No. (12,090,000 B2) it is not patentably distinct from claim 1 of patent ('546).
Conclusion
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/G.M./Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786