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 .
Claims Accounting
Applicant's arguments, filed 08/21/2025, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 08/21/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1 has been amended.
Claims 2-10 has been canceled.
Claims 11-13 are newly presented.
Claims 1 and 11-13 are the current claims hereby under examination.
Claim Objections
Claim 1 is objected to because of the following informalities:
in claim 1, line 1: “a” should be inserted before “human”.
Appropriate correction is required.
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.
Claims 1 and 11-13 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.
Claim 1 recites “0.1% to 30% by weight of a thermosensitive/thermochromic colorant in powder form and, 3% by weight of a catalyst”. There is insufficient support in the written description for the determinations of the amounts of the components of the thermosensitive silicone plate to be measured by weight.
All claims not explicitly rejected under 35 U.S.C. 112(a) are rejected by virtue of their dependence on a rejected base claim.
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.
Claim 13 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.
Regarding claim 13, the claim recites “the color change” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Also, it is not clear if this color change is the same as, related to, or different from the visually discernible temperature patterns of claim 1. The relationship between these two recitations should be made clear. Clarification is requested.
Claim 13 recites “wherein the color change of the thermosensitive silicone plate occurs within seconds upon contact with brain tissue” in lines 1-3, which is an action step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
For the purposes of examination, the claim is interpreted as “wherein the thermosensitive plate is configured to exhibit a color change occurring within seconds upon contact with brain tissue.”
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2011/0098609 by Hall et al. – previously cited (hereinafter “Hall”) in view of US Patent Publication 2022/0211547 by McClellan et al. – previously cited (hereinafter “McClellan”) in view of US Patent Publication 2019/0346602 by Okumura et al. – previously cited (hereinafter “Okumura”) in view of Chinese Patent CN 105220859 by Zhao – previously cited (hereinafter “Zhao”) in view of US Patent Publication 2014/0257052 by Muller – previously cited (hereinafter “Muller”), as evidenced by US Patent Publication 2020/0093474 by Macknik et al. – previously cited (hereinafter “Macknik”).
Regarding claim 1, Fig. 1 of Hall teaches a thermosensitive plate (temperature indicating element 1) for qualitative measurements of human cortical brain during neurosurgery for identifying zones of metabolic activation or different metabolism, comprising:
a thermosensitive plate comprising:
a temperature irradiation surface configured to be placed in contact exposed brain tissue (the side of the plate facing the subject),
a temperature irradiation surface opposite to the temperature transfer surface (the top side of the plate not contacting the subject);
a conduction plane disposed between the temperature transfer surface and the temperature irradiation surface (the plane parallel with the bottom surface of the plate contacting the subject),
wherein the thermosensitive plate has a uniform thickness is from 1 to 5 mm ([0060]; Preferably the thickness of the temperature indicating element is 0.30 to 5 mm. This includes the range of 1 mm to 5 mm; Fig. 1 shows the temperature indicating element 1 with a uniform thickness.) .
It is noted that the thermosensitive plate of Hall is capable of being used to show several identifiable temperature patterns on the temperature irradiation surface in response to temperature variations at the temperature transfer surface when in contact with brain tissue, as several differences in temperature of the tissue would cause several identifiable temperature patterns in the thermosensitive plate. Thus, Hall teaches wherein the thermosensitive plate is configured to display visually discernible temperature patterns on the temperature irradiation surface in response to temperature variations at the temperature transfer surface when in contact with the brain tissue.
Hall does not teach the thermosensitive plate being made of silicone or comprising thermochromic pigment.
Fig. 1 of McClellan teaches a silicone sheet for be applied to the skin of a subject with additives including thermochromic pigment to show temperature change. Macknik teaches that silicone makes an ideal material for contact with the brain as it is a biocompatible, flexible material that can provide pressure on the brain to ensure contact without exerting a damaging pressure on the brain surface (Macknik, [0030]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the thermosensitive plate of Hall to be made of silicone with a thermochromic pigment additive as taught by McClellan, as this material is biocompatible and can maintain contact with the brain without exerting damaging pressure on the brain surface (Macknik, [0030]). It is noted that Hall discloses that other temperature responsive polymers may be used when biocompatible with the type of tissue (Hall, [0061]). It is further noted that silicone is a flexible material, therefore the combination of Hall and McClellan comprises a flexible thermosensitive plate.
The combination of Hall and McClellan does not teach the thermosensitive plate composed of liquid silicone, thermosensitive/thermochromic colorant in powder form of 0.1% to 30% by weight.
Okumura teaches a thermochromic material comprising a silicone resin and a thermochromic material in the range of ratios of 1% to 25% by mass ([0035]). This range of thermochromic material additive enables a material with reversible color changing properties ([0035]). It is noted that mixing ratios by mass are equivalent to mixing ratios by weight when measured under constant gravity.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have used thermochromic pigment in the amount of 1 to 25% by weight, falling within the range of 0.1 to 30%by weight, as taught by Okumura to enable a thermochromic material with reversible color changing, as taught by Okumura ([0035]).
The combination of Hall, McClellan, and Okumura do not teach the thermosensitive plate composed of room temperature vulcanized (RTV) liquid silicone and 3% by weight of a catalyst.
Zhao teaches that mixing liquid silicone with a curing agent (e.g. catalyst) to make a room temperature curable composition (RTV silicone) in the ratio of 100:3 by weight. This ratio allows the mixture to cure at room temperature (Zhao; Manufacturing step 3: making the silica gel die).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have used room temperature vulcanized (RTV) liquid silicone and 3% by weight of a catalyst, as taught by Zhao, as this is a known ratio to create silicone that cures at room temperature.
The terms “liquid” of the phrase “liquid silicone” and “powder form” of the phrase “colorant in powder form” are being treated as a product-by-process limitations and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. Therefore, even though the combination of Hall, McClellan, Okumura and Zhao are silent as to the form of the colorant used to create the thermosensitive plate, the combination would be the same or similar as that claimed.
The combination of Hall, McClellan, Okumura, and Zhao does not teach the thermosensitive silicone plate comprising: and at least one electrode placed on the temperature irradiation surface for measuring electrical activity.
Fig. 1 of Muller teaches a system comprising a thin polymer film to be placed on the brain with an electrode array ([0084]). The electrode array allows for the monitoring of neural electrical activity ([0032]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the flexible thermosensitive plate taught by the combination of Hall, McClellan, Okumura, and Zhao by including at least one electrode to measure electrical activity placed on the temperature irradiation surface to allows for the monitoring of neural electrical activity as taught by Muller ([0032]), to gain a more comprehensive understanding of the patient’s health.
Regarding claim 13, The combination of Hall, McClellan, Okumura, Zhao, and Muller teaches the flexible thermosensitive plate of claim 1, wherein the color change of the thermosensitive silicone plate occurs within seconds upon contact with brain tissue (The thermosensitive plate is capable of being placed into contact with the brain tissue and the thermosensitive plate changes color. Any amount of time it takes for the plate to change color will comprise a number of seconds, therefore the color change occurs within seconds).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of McClellan in view of Okumura in view of Zhao in view of Muller, as evidenced by Macknik, in view of US Patent Publication 2005/0281385 by Johnson – previously cited (hereinafter “Johnson”).
The combination of Hall, McClellan, Okumura, Zhao, and Muller teaches the flexible thermosensitive plate of claim 1, but does not teach further comprising locators of compatible material to be detected by navigation systems placed on the temperature irradiation surface.
Johnson teaches using materials compatible with a navigation system placed on a thin marker holding sheet made of polymer ([0054]). This allows for the navigation of a tool or instrument involved in the procedure ([0011]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the thermosensitive plate taught by the combination of Hall, McClellan, Okumura, Zhao, and Hall to include one or more locators of compatible material placed on the temperature irradiation surface, for detection by surgical navigation systems, to allow for image guided surgery and aid in the navigation of a tool or instrument involved in the procedure, as taught by Johnson ([0011]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of McClellan in view of Okumura in view of Zhao in view of Muller, as evidenced by Macknik, in view of US Patent Publication 2010/0130839 by Dowling (hereinafter “Dowling”).
The combination of Hall, McClellan, Okumura, Zhao, and Muller teaches the flexible thermosensitive plate of claim 1, but does not teach wherein the thermosensitive silicone plate is phosphorescent in addition to being thermosensitive and thermochromic.
Fig. 4 of Dowling teaches a method of determining a concentration of oxygen based on light emitted from photoluminescent molecules embedded in silicone rubber that is in contact with the tissue to be measured ([0078]). The photoluminescent molecules may be phosphorescent molecules ([0046]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the flexible thermosensitive plate taught by adding phosphorescent molecules to enable the monitoring of oxygen of the tissue, as taught by Dowling ([0046, 0078]). The ability to simultaneously monitor oxygen would provide a more comprehensive understanding of a patient’s health.
Response to Arguments
Applicant’s arguments, filed 08/21/2025, are acknowledged and have been fully considered.
Applicants amended drawings overcomes the previous objection of record.
Applicant’s amended specification overcomes the previous objection of record.
The amendments to claim 1 overcome the rejections under 35 U.S.C. 112(b), however, the amendments to the claim result in a new rejection under 35 U.S.C. 112(b).
Applicant's arguments regarding the rejections under 35 U.S.C. 103, the arguments are against the references individually. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The flexible thermosensitive plate taught by the combination of Hall, McClellan, Okumura, Zhao, and Muller relies on teachings and components of each of the references. Further, each reference need not teach all of the limitations of the claim, or only teach limitations related to the claim. Applicant’s arguments that Hall teaches a thermosensitive plate that is transparent to ultrasound to be compatible with an ultrasound instrument is not found persuasive, as the temperature indicating element of Hall is capable of being used in a different manner. Similar arguments regarding the intended use of McClellan, Macknik, Okumura, Zhao, Muller, and Johnson are similarly not found persuasive.
With respect to argument that the references are not directed towards use in neurosurgery, this argument is not commensurate in scope with the claims. The claims recite the intended use of the plate as being for neurosurgery, however the intended use of the device does not impart any structure to the device. Therefore, any flexible thermosensitive plate comprising the claimed elements is capable of being used in neurosurgery.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/NELSON ALEXANDER GLOVER/ Examiner, Art Unit 3791
/MATTHEW KREMER/ Primary Examiner, Art Unit 3791