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 .
Information Disclosure Statement
The listing of references in the specification [0006-7] is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
A preliminary examination of this application reveals that it includes terminology which is different from that which is generally accepted in the art to which this invention pertains: [0005] indicates imaging modalities such as X-ray, MRI etc. as invasive means – however, these are generally considered non-invasive since there’s no incision/insertion into the body in contrast to those considered invasive such as intravascular ultrasound. Clarification is requested.
If such elements will be claimed, Applicant is to provide a correlation with art-accepted terminology. Applicant should be careful not to introduce any new matter into the disclosure (i.e., matter which is not supported by the disclosure as originally filed).
Claim Objections
Claims 1, 3-7 are objected to because of the following informalities: all subsequent “superficial anatomy” after the first instance in each independent claims [1, 6 and 7] should be “the superficial anatomy”. Appropriate correction is required.
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.
Claim 7 is 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 7 appears to encompass a human with limitation “the patient having a patient medial line”. It is suggested the claim be amended to remove that limitation with “… the surface conforms to a negative image of a modified topology of a subject area of superficial anatomy of the patient in neutral spine posture with the medial line axis aligned to correspond to a patient medial line…”
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, 6 and associated dependent claims 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.
The term “best” in said claims is a relative term which renders the claim indefinite. The term “best” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by “Pedtke”, US Publication 20170079828.
Regarding claims 1, Pedtke discloses a device for postural assessment and therapy of a patient [abstract]. The claim and associated dependent claims are treated as product-by-process claim as stipulated by the limitation “made by”. Examiner takes the position that the structural limitation imparted by the recited “made by” steps result in the “physical surface that a negative image of the mathematical surface model” which is disclosed by Pedtke [0123+].
Regarding claim 2, Pedtke discloses the structural limitation imparted by modifying the topological model to obtain the mathematical surface model comprises disregarding displacement along a horizontal plane [fig. 2b; e.g., dorsal half via horizontal separation from ventral half].
Regarding claim 3, Pedtke discloses the structural limitation imparted by modifying the topological model to obtain the mathematical surface model comprises flattening topographic maxima corresponding to protrusions due to skeletal features in the subject area of superficial anatomy [fig. 2b; e.g., smooth surface]
Regarding claim 4, Pedtke discloses the structural limitation imparted by modifying the topological model to obtain the mathematical surface model comprises adding channels to correspond to protrusions due to skeletal features on the subject area of superficial anatomy [fig. 2b; e.g., 338, 330].
Regarding claim 5, Pedtke discloses the structural limitation imparted by modifying the topological model to obtain the mathematical surface model comprises adding channels corresponding to areas of extremity flexion and extension on the subject area of superficial anatomy [0010, 0012; e.g., spinal column].
Regarding claim 7, Pedtke discloses a device for computer-aided postural assessment and therapy of a patient [e.g., fig. 2b, 4, 7], comprising:
a sequence of planar segments, each planar segment disposed on a medial line axis allowing rotational displacement from a neutral position [0010+; planar segments are broadly interpreted to any regions that conform/rotate/flex around the spinal axis], each planar segment further having an upper edge configuration [0008+; initial configuration], the upper edge configuration of the sequence of planar segments forming a surface such that, when all planar segments are in the neutral position [e.g., no flexing or movement], the surface conforms to a negative image of a modified topology of a subject area of superficial anatomy of the patient in neutral spine posture [0017+; initial negative would be from the initial 3d model], the patient having a patient medial line [humans with spinal vertebrae], the medial line axis [e.g., spinal column] aligned to correspond to the patient medial line [0010+]; and
a set of sensors, each sensor assigned to a planar segment and transmitting, to a computer, a signal corresponding to the rotational displacement of the planar segment from the neutral position [0146+].
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Pedtke” as applied to claim 1 above, and further in view of “Cheng”, US Publication 20160310064.
Regarding claim 6, Pedtke discloses a device for postural assessment and therapy of a patient as discussed above – “computer-aided” is also interpreted under product-by-process that imparts no structure to the product. Additionally, examiner takes the position that the structural limitation imparted by the recited “made by” steps result also in the “physical surface with a network of sensors configured to provide a stream of sensor data to a computer” which is disclosed by Pedtke [0144+].
Pedtke did not disclose explicitly pressure sensors. Cheng discloses a similar device for postural assessment and therapy of a patient with the physical surface with a network of pressure sensors configured to provide a stream of pressure sensor data [0065+].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the pressure sensors as taught explicitly by Cheng in order to enhance diagnosis and monitoring/tracking posture [0066+; check deviation from healthy posture].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tse Chen whose telephone number is (571)272-3672. The examiner can normally be reached M-F 7-3 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jonathan Moffat can be reached at 571-272-4390. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791