DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
1. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
2. Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The Applicant has amended claims 1 and 16 to include user- specific calibration and biofeedback mechanisms configured to dynamically adjust treatment parameters in real-time based on patient responses, enhancing treatment precision and safety and depth sensing. However, it is unclear what how the “user-specific” calibration works and how the “patient responses are considered. For instance, is any/all calibration specific to the patient? It is also unclear what the responses are in response to. There is a lack of description/clarity in terms of what these things structurally entail/encompass. The specification does not provide any working examples, guidance, or steps as to how this function is achieved. Rather, the specification only mentions the use of a predictive model.
As noted in the MPEP, original claims may lack written description when the claims define the invention in functional language specifying a desired result, but the specification does not sufficiently describe how the function is performed, or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient).
It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
3. Claim(s) 1-9, 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hipsley (US 2014/0316388 A1) in view of Teiwes (US 20050024586 A1).
In regards to claims 1 and 16, Hipsley discloses a system and method for delivering microporation medical treatments to improve biomechanics (e.g. paragraph [0055] states that Hipsley’s invention relates to the creation of one or more matrices of pores in the aged connective tissue to restore the lost biomechanical properties of the connective tissue), the system comprising:
a laser for generating a beam of laser radiation on a treatment-axis not aligned with a patient's visual-axis, operable for use in subsurface ablative medical treatments to create an array pattern of micropores that improves biomechanics; a housing; a controller within the housing, in communication with the laser and operable to control dosimetry of the beam of laser radiation in application to a target tissue; a lens operable to focus the beam of laser radiation onto a target tissue (e.g. paragraphs [0008, 0059-0061, 0066] state that the device for delivering medical treatments comprises a laser for generating a beam of laser radiation, a housing, a controller within the housing, in communication with the laser and operable to control the qualities of the beam of laser radiation in application to a target material, a lens operable to focus the beam of laser radiation onto a target material, and a power source operable to provide power to the laser and controller);
an automated off-axis subsurface anatomy tracking, measuring, and avoidance system (e.g. paragraph [0071] discloses a scanning mechanism or system, such as eye tracker 304 in Fig. 4, configured to move the laser energy in the pore matrix over the tissue that can be an automated process, paragraph [00167] disclose an anatomy avoidance system to identify critical biological obstacles or locations during procedures, paragraphs [0073, 0190-0191] disclose a biofeedback loops that include a sensor that offer real-time position feedback, to allow ablation of target tissue and protect or avoid surrounding tissue, by sensing location, depth, size, shape, or other parameters of an ablation profile);
the automated off-axis subsurface anatomy tracking, measuring, and avoidance system including at least one of a laser delivery mechanism capable of rotational movement around a fixation point, and an advanced imaging system with off-centerline placement, zoom capabilities for comprehensive visualization, and color imaging for depth sensing, enhancing off-axis laser bean delivery, tracking, and treatment accuracy (Par. 0088 discloses that the laser system is rotatable about an axis/fixation point); and
wherein the array pattern of micropores is at least one of a radial pattern (Fig. 22), a spiral pattern (Fig. 20), a phyllotactic pattern (Fig. 21), or an asymmetric pattern (paragraph [0055] states that the pores matrices may comprises a random nano-patterns).
Hipsley does not teach including user- specific calibration and biofeedback mechanisms configured to dynamically adjust treatment parameters in real-time based on patient responses, enhancing treatment precision and safety and depth sensing. However, in the same field of endeavor, Teiwes teaches an ophthalmic treatment device (Abstract) wherein there is a closed loop eye tracker that takes in feedback signals to make adjustments and a calibration system (Par. 0021 and 0064) in order to allow for automatic, user-friendly and service-friendly maintenance.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Hipsley and modified them by having the system include a calibration and feedback system, as taught and suggested by Teiwes, in order to allow for automatic, user-friendly and service-friendly maintenance.
In regards to claim 2 and 17, the combined teachings of Hipsley and Teiwes further disclose the limitation wherein the array pattern of micropores is a spiral pattern of an Archmedean spiral, a Euler spiral, a Fermat’s spiral, a hyperbolic spiral, a lituus, a logarithmic spiral, a Fibonacci spiral, a golden spiral, or combination thereof (e.g. paragraphs [0024-0026] of Hipsley, Fig. 20 of Hipsley).
In regards to claims 3-6 and 18-20, the combined teachings of Hipsley and Teiwes state that the ablation patterns may be formed in various configurations, which can be asymmetry or symmetry, and is controlled by the delivery system to serve the purpose of altering the properties of the connective tissue to improve the biomechanics thereof (e.g. paragraphs [0055, 0192-0214] of Hipsley).
In regards to claims 7-9, the combined teachings of Hipsley and Teiwes disclose the limitation wherein the array pattern has a number of clockwise spirals and a number of counter-clock wise spirals (e.g. Fig. 20 of Hipsley shows pores pattern 2000). Paragraphs [0224-0227] of Hipsley state that the pores pattern may trace out a golden spirals, clockwise, counterclockwise and combined, with a golden number of 1.618 for each quarter turn of the spiral).
In regards to claims 14-15, the combined teachings of Hipsley and Teiwes disclose the limitation wherein the array pattern of micropores has a random asymmetry or a random symmetry (e.g. paragraph [0055] of Hipsley, Figs. 12-19 of Hipsley).
Prior Art
4. Claims 10-13 do not currently have art rejections. However, the U.S.C. 112a rejection needs to be addressed. Should any future amendments change the scope of the claims, then further search and consideration will be needed.
Conclusion
This is a continuation of applicant's earlier Application No. 17/322873. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.L.C./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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