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 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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-19, 25-29, 35-38, and 46 in the reply filed on 2 April 2026 is acknowledged.
Claims 20-24, 30-34, and 39-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2 April 2026.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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 1-19 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 1 recites an effective amount or a derivative thereof. This would appear to indicate that ethanol or a derivative thereof is required to be present. However, claim 7, which depends upon claim 1, recites that the ratio of water to ethanol (or a derivative thereof) may be 100:0. This would appear to indicate that a composition with zero ethanol or a derivative thereof is within the claim scope. Therefore, it is unclear whether the claims require that ethanol or a derivative thereof be present in the composition.
For the purposes of examination under prior art, claim 1 is understood to require ethanol or a derivative thereof, and claim 7 is understood to limit the ethanol concentration to be about 50:50 with water.
Claims 25-29 and 35-38 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 25 recites neurolytic agents “such as” ethanol or phenol. Claim 35 similarly recites “such as” ethanol.
Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. See MPEP 2173.05(d). In this case, it is unclear if the claims are drawn to the full scope of neurolytic agents or only to ethanol and phenol. See MPEP 2173.05(d), items (C) and (D).
For the purposes of examination under prior art, the examiner understands the claim to require the full scope of neurolytic agents.
Claim 36 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 36 recites a composition delivered via spraying. 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. See MPEP 2173.05(p)(II). In this case, claim 36 recites a composition (e.g. that of claim 35) but also recites a method step (e.g. delivered via spraying). As such, it is unclear whether the claim is drawn to a composition or a method.
For the purposes of examination under prior art, the examiner will proceed with the understanding that claim 36 is a composition capable of being delivered via spraying.
Claim 46 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 46 recites a composition. However, claim 46 depends upon claim 39, which is drawn to a method. As such, it is unclear whether claim 46 is drawn to a composition or to a method. This renders the claim indefinite. 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. See MPEP 2173.05(p)(II).
For the purposes of examination under prior art, claim 46 will be examined with the understanding that it requires a composition.
Claim Rejections - 35 USC § 112(d) – Failure to Limit Parent Claim
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 recites an effective amount of ethanol or a derivative thereof. However, claim 7, which depends upon claim 1, would appear to recite that the concentration of ethanol or a derivative thereof may be zero. This would appear to result in claim 7 being broader than claim 1 upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Interpretation
The instant claims require silicate nanoparticles. As best understood by the examiner, clay minerals are hydrous aluminum phyllosilicates, and thereby read on the required silicates.
Instant claim 1 recites a viscosity of about 2,000 to 15,000 mPa.s. The examiner notes that the instant application is drawn to a shear-thinning composition. This means that viscosity differs at different shear values. For the purposes of examination under prior art, a composition with a viscosity of 2,000 to 15,000 mPa.s at any value of shear is understood to meet the claim requirements. This means that a composition with a viscosity exceeding 15,000 mPa.s at zero shear but equal to 15,000 mPa.s at higher levels of shear is understood to meet the claimed requirement.
Claim 1 recites an ethanol derivative, as of the second line of the claim. This phrase does not appear to have been defined by the claims. Nevertheless, the examiner notes that the term “ethanol derivative” appears to have been used in the patent literature. See Seki et al. (US Patent 3,525,760), claim 5 and Dodson et al. (US Patent 6,150,126), claim 13. As such, the examiner understands that the phrase “ethanol derivative” is definite.
Claim 1 recites an effective amount of ethanol or a derivative thereof. This phrase is also recited in claims 25 and 35. MPEP 2173.05(c)(III) states that the common phrase "an effective amount" may or may not be indefinite. The proper test is whether or not one skilled in the art could determine specific values for the amount based on the disclosure. In this case, the instant specification appears to provide a definition for the phrase “effective amount” on page 5, paragraph 0046 of the specification. As such, the examiner understands the phrase “effective amount” to be definite. Prior art which teaches ethanol in the amount required by claim 7 is understood to meet the requirement of an effective amount of ethanol as required by claims 1, 25, and 35.
Regarding claim 27, the abbreviations in this claim are well-known. PNIPAM refers to poly(N-isopropyl acrylamide), PLGA to poly(lactide-co-glycolide) (sometimes referred to as poly(lactic-co-glycolic acid), PLA to polylactide (or polylactic acid), PEG to polyethylene glycol, and PVA to polyvinyl alcohol.
Claim Rejections - 35 USC § 102(a)(1) – Anticipation
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, 7, 10-16, 25-26, 28, and 35-36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kimura et al. (Langmuir, Vol. 33, 2017, pages 4758-4768 and supplemental pages 1-5).
Kimura et al. (hereafter referred to as Kimura) is drawn to combinations of water, alcohol (i.e. ethanol), and clay, as of Kimura, page 4758, title. The clay of Kimura appears to be in the form of a nanoparticle, as of Kimura, page 4759, figure 1, reproduced in part below.
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The examiner notes that the above-reproduced figure, as of the top left, provides size measurements which would indicate that the clay is in the form of a nanoparticle.
As to claim 25, the claim recites that the composition is for use in neurolysis. Kimura does not teach this. Nevertheless, as the composition of Kimura has all of the ingredients required by the instant claims, the skilled artisan would have expected that the composition of Kimura would have been usable in neurolysis even if Kimura does not explicitly teach this intended use. Something which is old (e.g. the composition of Kimura, which comprises water, alcohol and clay) does not become patentable upon the discovery of a new property (that a composition having water, alcohol, and silicates such as clay is usable in neurolysis), and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II). Additionally, the discovery of a previously unappreciated property of a prior art composition does not render the old composition patentably new to the discoverer. See MPEP 2112(I). See also MPEP 2114(II).
As to claim 25, the claims require an effective amount of ethanol. The examiner understands Kimura to teach this because Kimura teaches ethanol in an amount between about 100:0 to about 50:50 by weight, as required by claim 7. See the section of the office action above entitled “Claim Interpretation” as well as the rejection of claim 7 below.
As to claim 26, the skilled artisan would have expected the composition of Kimura to have been able to provide an implant for at least a day upon injection even though Kimura did not explicitly teach this. The discovery of a previously unappreciated property of a prior art composition does not render the old composition patentably new to the discoverer. See MPEP 2112(I). Additionally, once a reference teaching a product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant. See MPEP 2112(V). In this case, the prior art teaches a composition having water, ethanol, and clay, which is a silicate and is in the form of a nanoparticle; this appears to be substantially identical to the instantly claimed invention. This composition of Kimura appeared to show thixotropic (i.e. a type of shear thinning) behavior, as of Kimura, page 4578, abstract, which while not required by the claim, is discussed in the instant application. This teaching of thixotropic behavior is understood to be sufficient to shift the burden to applicant in accordance with MPEP 2112(V) in regard to the subject matter required by claim 26.
As to claim 28, this claim is rejected for essentially the same reason that claim 26 is rejected.
As to claim 35, Kimura teaches ethanol, clay particles which read on the required silicate nanoparticles, and water. The claim recites that the composition is for use in for ablation of residual tumor cells post-surgical resection. Kimura does not teach this. Nevertheless, as the composition of Kimura has all of the ingredients required by the instant claims, the skilled artisan would have expected that the composition of Kimura would have been usable in ablation even if Kimura does not explicitly teach this intended use. Something which is old (e.g. the composition of Kimura, which comprises water, alcohol and clay) does not become patentable upon the discovery of a new property (that a composition having water, alcohol, and silicates such as clay is usable in ablation), and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II). Additionally, the discovery of a previously unappreciated property of a prior art composition does not render the old composition patentably new to the discoverer. See MPEP 2112(I). See also MPEP 2114(II).
As to claim 36, the limitation that the composition is delivered by spraying further limits how the composition is used rather than the composition itself. This is not sufficient to overcome the applied rejection because the composition of Kimura could have been used by spraying, even if it was not actually used in this manner. Apparatus claims limit what a device is, not what a device does, and the examiner understands this rationale to apply to composition claims. See MPEP 2114(II).
As to claim 1, Kimura teaches the following, as of page 4761, figure 4(d), reproduced below with caption.
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This figure discloses multiple compositions with water, ethanol, and clay (a silicate), which have viscosities between 2000 and about 9000 MPa.s in certain examples.
As to claims 2-3, the rationale provided by the examiner regarding MPEP 2112(I &) and MPEP 2112(V) in regard to claims 26-28 also applies to claims 2-3.
As to claim 4, Kimura teaches an example comprising 5% clay (i.e. silica derivatives) to e.g. 20-30% ethanol in figure 4(d), reproduced above. This is an ethanol:clay ratio of 1:0.16, which would appear to be within the claim scope.
As to claim 5, Kimura teaches 5% clay (i.e. silica) particles; this appears to be within the claim scope.
As to claim 7, Kimura teaches multiple examples where the ethanol content would appear to be about 35-40% by weight, the silicate (i.e. clay) content would be 5% by weight, and the water would be the remaining 55-60%, as of Kimura, page 4761, right column, figure 4.
As to claim 10, the examiner understands the clays of Kimura to be silicate nanoplatelets. See Kimura, page 4759, figure 1(a), reproduced above.
As to claim 11, the nanoplatelets of Kimura appear to have a negatively charged surface and a positively charged edge as of Kimura, page 4759, figure 1(a)(iii), reproduced above.
As to claim 12, the nanoplatelets of Kimura appear to be negatively charged, as of Kimura, page 4759, figure 1(a)(ii).
As to claims 13-14, Kimura appears to teach a 30 nm diameter and 1 nm thickness as of page 4759, figure (1)(a)(i), reproduced in the above anticipation rejection.
As to claim 15, Kimura appears to be silent regarding yield stress. Nevertheless, something which is old does not become patentable upon the discovery of a new property, and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II). Additionally, once a reference teaching a product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant. See MPEP 2112(V). In this case, the prior art teaches a composition having water, ethanol, and clay, which is a silicate and is in the form of a nanoparticle; this appears to be substantially identical to the instantly claimed invention. This composition of Kimura appeared to show thixotropic (i.e. a type of shear thinning) behavior, as of Kimura, page 4578, abstract, which while not required by the claim, is discussed in the instant application. This teaching of thixotropic behavior is understood to be sufficient to shift the burden to applicant in accordance with MPEP 2112(V) in regard to the subject matter required by claim 15.
As to claim 16, Kimura teaches that the composition is thixotropic, as of Kimura, page 4758, abstract.
Claim Rejections - 35 USC § 103 – Obviousness
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-16, 25-26, 28, and 35-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al. (Langmuir, Vol. 33, 2017, pages 4758-4768 and supplemental pages 1-5).
Kimura et al. (hereafter referred to as Kimura) is drawn to combinations of water, alcohol, and clay, as of Kimura, page 4758, title. The clay of Kimura appears to be in the form of a nanoparticle, as of Kimura, page 4759, figure 1, reproduced in the anticipation rejection above. The examiner notes that said figure, as of the top left, provides size measurements which would indicate that the clay is in the form of a nanoparticle.
As to claim 25, the claim recites that the composition is for use in neurolysis. Kimura does not teach this. Nevertheless, as the composition of Kimura has all of the ingredients required by the instant claims, the skilled artisan would have expected that the composition of Kimura would have been usable in neurolysis even if Kimura does not explicitly teach this intended use. Something which is old (e.g. the composition of Kimura, which comprises water, alcohol and clay) does not become patentable upon the discovery of a new property (that a composition having water, alcohol, and silicates such as clay is usable in neurolysis), and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II). Additionally, the discovery of a previously unappreciated property of a prior art composition does not render the old composition patentably new to the discoverer. See MPEP 2112(I). See also MPEP 2114(II).
As to claim 25, purely en arguendo and for the purposes of this ground of rejection only, the examiner takes the position that Kimura teaches all of the claimed requirements, but not together in the same embodiment. As such, while the prior art teaches all of the claimed components, the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 25, the claims require an effective amount of ethanol. The examiner understands Kimura to teach this because Kimura teaches ethanol in an amount between about 100:0 to about 50:50 by weight, as required by claim 7. See the section of the office action above entitled “Claim Interpretation” as well as the rejection of claim 7 below.
As to claim 26, the skilled artisan would have expected the composition of Kimura to have been able to provide an implant for at least a day upon injection even though Kimura did not explicitly teach this. The discovery of a previously unappreciated property of a prior art composition does not render the old composition patentably new to the discoverer. See MPEP 2112(I). Additionally, once a reference teaching a product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant. See MPEP 2112(V). In this case, the prior art teaches a composition having water, ethanol, and clay, which is a silicate and is in the form of a nanoparticle; this appears to be substantially identical to the instantly claimed invention. This composition of Kimura appeared to show thixotropic (i.e. a type of shear thinning) behavior, as of Kimura, page 4578, abstract, which while not required by the claim, is discussed in the instant application. This teaching of thixotropic behavior is understood to be sufficient to shift the burden to applicant in accordance with MPEP 2112(V) in regard to the subject matter required by claim 26. The examiner further notes here that MPEP 2112(V) states that whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.
As to claim 28, this claim is rejected for essentially the same reason that claim 26 is rejected.
As to claim 35, Kimura teaches ethanol, clay particles which read on the required silicate nanoparticles, and water. The claim recites that the composition is for use in for ablation of residual tumor cells post-surgical resection. Kimura does not teach this. Nevertheless, as the composition of Kimura has all of the ingredients required by the instant claims, the skilled artisan would have expected that the composition of Kimura would have been usable in ablation even if Kimura does not explicitly teach this intended use. Something which is old (e.g. the composition of Kimura, which comprises water, alcohol and clay) does not become patentable upon the discovery of a new property (that a composition having water, alcohol, and silicates such as clay is usable in ablation), and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II). Additionally, the discovery of a previously unappreciated property of a prior art composition does not render the old composition patentably new to the discoverer. See MPEP 2112(I). See also MPEP 2114(II).
As to claim 36, the limitation that the composition is delivered by spraying further limits how the composition is used rather than the composition itself. This is not sufficient to overcome the applied rejection because the composition of Kimura could have been used by spraying, even if it was not actually used in this manner. Apparatus claims limit what a device is, not what a device does, and the examiner understands this rationale to apply to composition claims. See MPEP 2114(II).
As to claim 1, Kimura teaches the following, as of page 4761, figure 4(d), reproduced below with caption.
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This figure discloses multiple compositions with water, ethanol, and clay (a silicate), which have viscosities between 2000 and about 9000 MPa.s in certain examples.
As to claims 2-3, the rationale provided by the examiner regarding MPEP 2112(I &) and MPEP 2112(V) in regard to claims 26-28 also applies to claims 2-3.
As to claim 4, Kimura teaches an example comprising 5% clay (i.e. silica derivatives) to e.g. 20-30% ethanol in figure 4(d), reproduced above. This is an ethanol:clay ratio of 1:0.16, which would appear to be within the claim scope.
As to claim 5, Kimura teaches 5% clay (i.e. silica) particles; this appears to be within the claim scope.
As to claim 6, Kimura teaches 5% clay rather than 10% clay in the above example. Nevertheless, the skilled artisan would have been motivated to have optimized the amount of clay to have been in the claimed range. Optimization of a result-effective variable is prima facie obvious. See MPEP 2144.05(II)(B). In this case, clay concentration is clearly a result-effective variable because the purpose of the Kimura reference is to test different clay concentrations and report on their properties. Additionally, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of a mixture of water, ethanol, and clay has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have determined the optimum or workable ranges of silica particle concentration via routine experimentation.
As to claim 7, Kimura teaches multiple examples where the ethanol content would appear to be about 35-40% by weight, the silicate (i.e. clay) content would be 5% by weight, and the water would be the remaining 55-60%, as of Kimura, page 4761, right column, figure 4.
As to claims 8-9, it does not appear as if the examples of Kimura anticipate these ranges. Nevertheless, the teachings of Kimura appear to be drawn to modifying and testing different ratios of water, ethanol, and clay. As such, the skilled artisan would have been motivated to have optimized the ratio of clay (i.e. silicate nanoparticles) to ethanol. Optimization of a result-effective variable is prima facie obvious. See MPEP 2144.05(II)(B). In this case, the teachings of Kimura are drawn to testing different ratios of ingredients; as such, the skilled artisan would have understood the clay to ethanol ratio to have been a result-effective variable and would have been motivated to have optimized this ratio.
As to claim 10, the examiner understands the clays of Kimura to be silicate nanoplatelets. See Kimura, page 4759, figure 1(a), reproduced above.
As to claim 11, the nanoplatelets of Kimura appear to have a negatively charged surface and a positively charged edge as of Kimura, page 4759, figure 1(a)(iii), reproduced above.
As to claim 12, the nanoplatelets of Kimura appear to be negatively charged, as of Kimura, page 4759, figure 1(a)(ii).
As to claims 13-14, Kimura appears to teach a 30 nm diameter and 1 nm thickness as of page 4759, figure (1)(a)(i), reproduced in the above anticipation rejection.
As to claim 15, Kimura appears to be silent regarding yield stress. Nevertheless, something which is old does not become patentable upon the discovery of a new property, and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II). Additionally, once a reference teaching a product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant. See MPEP 2112(V). In this case, the prior art teaches a composition having water, ethanol, and clay, which is a silicate and is in the form of a nanoparticle; this appears to be substantially identical to the instantly claimed invention. This composition of Kimura appeared to show thixotropic (i.e. a type of shear thinning) behavior, as of Kimura, page 4578, abstract, which while not required by the claim, is discussed in the instant application. This teaching of thixotropic behavior is understood to be sufficient to shift the burden to applicant in accordance with MPEP 2112(V) in regard to the subject matter required by claim 15.
As to claim 16, Kimura teaches that the composition is thixotropic, as of Kimura, page 4758, abstract.
Claim(s) 17-19, 27, 29, 37-38, and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al. (Langmuir, Vol. 33, 2017, pages 4758-4768 and supplemental pages 1-5) in view of Oreffo et al. (US 2017/0043058 A1).
Kimura is drawn to compositions made of water, ethanol, and clay. See the rejection above over Kimura by itself. Kimura teaches health care applications of these compositions, as of Kimura, page 4758, bottom of left column.
Kimura does not teach a chemotherapeutic agent and does not teach a polymer.
Oreffo et al. (hereafter referred to as Oreffo) is drawn to a polymer-clay composite, as of Oreffo, title and abstract. Oreffo teaches use of this composite for drug delivery, as of Oreffo, paragraph 0005 as well as other locations in the reference.
Oreffo does not appear to teach ethanol.
It would have been prima facie obvious for one of ordinary skill in the art to have used the ethanol, clay, and water combination of Kimura for drug delivery, as taught by Oreffo. Kimura teaches that an ethanol, clay, and water combination is useful for various applications including health care applications. Oreffo teaches that clay is useful in drug delivery applications. As such, the skilled artisan would have been motivated to have combined the composition of Kimura with pharmaceutical drugs to be delivered for predictable delivery of said drugs with a reasonable expectation of success.
As to claim 17, Oreffo teaches a diagnostically active substance, as of paragraph 0036. Oreffo teaches colourants, dyes, and radioisotopes as of paragraph 0037. These are understood to read on the required contrast agent.
As to claim 18, Oreffo teaches cis-platin in paragraph 0038, which is a chemotherapeutic agent.
As to claim 19, Oreffo teaches various materials in paragraph 0038 which read on the required biological agents.
As to claim 27, Oreffo teaches the inclusion of various polymers to help deliver drugs such as PLGA, as of Oreffo, paragraph 0034. As such, the skilled artisan would have been motivated to have included the PLGA of Oreffo in the composition of Kimura in view of Oreffo to have predictably advanced the healthcare application of drug delivery with a reasonable expectation of success.
As to claim 29, this claim is rejected for essentially the same reason that claim 17 is rejected.
As to claim 37, Oreffo teaches a diagnostically active substance, as of paragraph 0036. Oreffo teaches colourants, dyes, and radioisotopes as of paragraph 0037. These are understood to read on the required contrast agent.
As to claim 38, Oreffo teaches the inclusion of various polymers to help deliver drugs such as PLGA, as of Oreffo, paragraph 0034. As such, the skilled artisan would have been motivated to have included the PLGA of Oreffo in the composition of Kimura in view of Oreffo to have predictably advanced the healthcare application of drug delivery with a reasonable expectation of success.
As to claim 46, Oreffo teaches cis-platin in paragraph 0038, which is a chemotherapeutic agent.
Claim(s) 1, 6, 10-19, 25-27, 29, 35-38, and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khademosseini et al. (US 2018/0360920 A1) in view of Cho et al. (Korean Journal of Radiology, Vol. 9(3), June 2008, pages 258-267).
Khademosseini et al. (hereafter referred to as Khademosseini) is drawn to a shear-thinning composition for treating vascular disorders as an embolic agent, as of Khademosseini, title and abstract. Khademosseini teaches silicate nanoparticles, as of paragraph 0020, and water, as of paragraph 0036. Khademosseini teaches viscosity as of figures 8A, 8B, and 13.
Khademosseini does not teach ethanol.
Cho et al. (hereafter referred to as Cho) is drawn to ethanol for embolization, as of Cho, page 258, title and abstract.
Cho does not appear to teach silicate nanoparticles.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the ethanol of Cho with the composition of Khademosseini. Khademosseini is drawn to an embolic agent, as of the title and abstract, and is therefore drawn to achieving embolization. Cho is drawn to ethanol for embolization, as of Cho, page 258, title and abstract. As such, the skilled artisan would have been motivated to have combined the ethanol of Cho with the composition of Khademosseini in order to have predictably achieved embolization with a reasonable expectation of success. Combining prior art elements (e.g. the composition of Khademosseini and the ethanol of Cho) according to known methods in order to have achieved predictable results (embolization) is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 1, the examiner has set forth the following chart on the next page to explain how the claimed subject matter lacks an inventive step in view of Khademosseini and Cho, as set forth on the next page.
Claim Limitation
Where Taught in Prior Art
A composition for use in ablation or sclerotherapy
Khademosseini teaches use in ablation in paragraphs [0113] and [0184]
Ethanol
Cho teaches ethanol, as of the title. Skilled artisan would have been motivated to have combined Cho with Khademosseini because both references relate to embolization.
Silicate Nanoparticles
See at least paragraph [0020] of Khademosseini
Water
See at least paragraph [0036] of Khademosseini
Required Viscosity
See figures 8A, 8B, and 13 of Khademosseini – the examiner notes that a shear thinning composition whose viscosity exceeds the claimed range at zero shear but is within the claimed range at non-zero shear meets this claim limitation.
Regarding viscosity, the examiner clarifies that the instant claims do not recite the shear force at which the recited viscosity occurs; this is relevant because both the prior art and instant invention (as per the title) are drawn to shear-thinning compositions. For example, figure 13 of Khademosseini has been reproduced below.
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452
716
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Greyscale
The above-reproduced figure appears to show a composition with zero viscosity at any shear value (represented by the circle), then a composition showing about 60-70 Pa*sec viscosity at zero shear (represented by the square). The value of 70 Pa*Sec is 70,000 mPa*sec, which would appear to exceed the maximum viscosity of 15,000 mPa*Sec. With that being said, the composition represented by the square having 70,000 mPa*sec viscosity at zero shear would appear to have a lower viscosity at higher shear that would have been within the required range of 2000-15,000 mPa*Sec. This would also appear to be applicable to all of the other compositions taught by figure 13 of Khademosseini with the exception of the composition having zero viscosity at all shear levels. As such, the viscosity of the compositions of Khademosseini would appear to be within the claim scope.
As to claim 1, the examiner notes that Khademosseini and Cho relate to embolization, whereas the intended use of the instantly claimed composition is for ablation or sclerotherapy. Nevertheless, this difference is not sufficient to overcome the applied rejection. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem (e.g. embolization in the case of the prior art, in contrast to ablation or sclerotherapy in the case of the claimed invention). It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See MPEP 2144(IV).
As to claim 1, the claims require an effective amount of ethanol. Cho teaches ethanol in amounts of 99.9%, 80%, as well as more dilute concentrations, as of Cho, page 250, beginning of second to last paragraph. These would appear to be effective amounts.
As to claim 6, Khademosseini teaches about 0.5% to about 10% of the silicate nanoparticles by weight, as of paragraph 0020 of Khademosseini.
As to claim 10, Khademosseini teaches silica nanoplatelets in paragraph 0023.
As to claim 11, Khademosseini teaches a positively charged edge and a negatively charged surface in paragraph 0023.
As to claim 12, Khademosseini teaches that the overall charge is negative, as of paragraph 0023.
As to claim 13, Khademosseini teaches an average diameter of about 5 nm to about 60 nm as of paragraph 0024.
As to claim 14, Khademosseini teaches an average thickness of about 1 nm in paragraph 0024.
As to claim 15, Khademosseini teaches a yield stress of about 1 Pa to about 200 Pa in paragraph 0049.
As to claim 16, Khademosseini teaches a shear-thinning composition in paragraph 0049.
As to claim 17, Khademosseini teaches a contrast agent in paragraph 0176. Khademosseini also teaches the term “radiopaque” in paragraph 0090; the skilled artisan would have understood that an agent for x-rays is a radiopaque agent.
As to claim 18, Khademosseini teaches chemotherapeutic agents as of at least paragraphs 0111 and 0162.
As to claim 19, Khademosseini teaches chemotherapeutic agents as of at least paragraphs 0111 and 0162. This reads on the required biological agents.
As to claim 25, this claim is rejected for essentially the same reason that claim 1 is rejected. Cho teaches ethanol, and Khademosseini teaches silicate nanoparticles and water. While neither reference teaches that the composition is for neurolysis, the skilled artisan would have expected the combination of Khademosseini in view of Cho to have been usable for neurolysis because it comprises all of the required elements. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. See MPEP 2112(I). Additionally, MPEP 2114(II) notes that apparatus claims cover what a device is, not what a device does; the examiner understands this rationale to apply to chemical composition claims in the same manner that it applies to apparatus claims.
As to claim 26, Khademosseini appears to teach that the composition stays in place for 24 days, as of Khademosseini, paragraphs 0104, 0106, and 0256-0257.
As to claim 27, Khademosseini teaches gelatin, as of paragraph 0019.
As to claim 29, Khademosseini teaches a contrast agent in paragraph 0176. Khademosseini also teaches the term “radiopaque” in paragraph 0090; the skilled artisan would have understood that an agent for x-rays is a radiopaque agent.
As to claim 35, this claim is rejected for essentially the same reason that claim 1 is rejected. Cho teaches ethanol, and Khademosseini teaches silicate nanoparticles and water. While neither reference teaches that the composition is for ablation, the skilled artisan would have expected the combination of Khademosseini in view of Cho to have been usable for ablation because it comprises all of the required elements. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. See MPEP 2112(I). Additionally, MPEP 2114(II) notes that apparatus claims cover what a device is, not what a device does; the examiner understands this rationale to apply to chemical composition claims in the same manner that it applies to apparatus claims.
As to claim 36, the skilled artisan would have expected that the composition of Khademosseini, whether by itself or modified by Cho, would have been capable of being delivered by spraying because it appears to be the same viscosity as the instantly claimed composition.
As to claim 37, Khademosseini teaches a contrast agent in paragraph 0176. Khademosseini also teaches the term “radiopaque” in paragraph 0090; the skilled artisan would have understood that an agent for x-rays is a radiopaque agent.
As to claim 38, Khademosseini teaches gelatin, as of paragraph 0019.
As to claim 46, Khademosseini teaches a chemotherapeutic agent, as of at least paragraph 0014.
Conclusion
No claim is allowed.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
Prosecution Insights