DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The Amendment filed on 12/29/2025 has been entered. Claims 1-20 remain pending in the application.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-7, 11, 12 and 18 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by United States Patent No. 4,320,761, hereinafter Haddad.
Regarding claim 1, Haddad teaches a method for selectively extracting biological material from a biological sample (abstract), comprising: identifying a region of biological material to be extracted from a biological sample (column 1, lines 10-27); disrupting biological material from the identified region of biological material in the biological sample with an extraction tool having a cutting tip (column 4, lines 24-33); dispensing a liquid at the region of biological material (column 4, lines 24-33), forming a suspension mixture of the liquid and the disrupted biological material (abstract); and aspirating the liquid and the disrupted biological material suspension mixture from the biological sample (column 4, lines 24-33).
Regarding claim 2, Haddad teaches wherein the extraction tool imparts a cutting motion to the region of biological material (column 4, lines 24-33).
Regarding claim 3, Haddad teaches wherein the cutting motion includes a motion selected from the group consisting of rotating (column 4, lines 20-33), vibrating, slicing, and combinations thereof.
Regarding claim 4, Haddad teaches wherein the cutting motion is rotating (column 4, lines 20-33).
Regarding claim 5, Haddad teaches wherein the liquid is dispensed at an interface between the region of biological material and the extraction tool (column 4, lines 24-33 and figure 9).
Regarding claim 6, Haddad teaches wherein the liquid is dispensed and aspirated simultaneously (column 4, lines 24-33).
Regarding claim 7, Haddad teaches wherein the liquid is dispensed and aspirated by the extraction tool (column 4, lines 24-33).
Regarding claim 11, Haddad teaches a method for selectively extracting biological material from a biological sample (abstract), comprising: identifying a region of biological material to be extracted from a biological sample (column 1, lines 10-27); mechanically disrupting biological material from the identified region of biological material from the biological sample with an extraction tool having a cutting tip (column 4, lines 24-33); and recovering the disrupted biological material from the biological sample using a liquid (column 4, lines 24-33), wherein the liquid and the disrupted biological material form a suspension (abstract) that is recovered from the biological sample (column 4, lines 24-33).
Regarding claim 12, Haddad teaches wherein the extraction tool is a milling machine (column 4, lines 24-33).
Regarding claim 18, Haddad teaches wherein the biological sample is a tissue sample (abstract).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-15 and 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over United States Application Publication No. 2010/0224013, hereinafter Van Berkel in view of WO 00/57153, hereinafter Bing.
Regarding claims 1-4, Van Berkel teaches a method for selectively extracting biological material from a biological sample (paragraph [0020]), comprising: identifying a region of biological material to be extracted from a biological sample (paragraphs [0027]-[0029]); disrupting biological material from the identified region of biological material in the biological sample with an extraction tool (paragraph [0024], item 25); dispensing a liquid at the region of biological material, forming a suspension of the liquid and the disrupted biological material (figure 5 and paragraphs [0024] and [0032], as seen in figure 5 there are some particles of the sample material (item 52) which are not dissolved, thereby forming a suspension); and aspirating the liquid and the disrupted biological material suspension from the biological sample (figure 5 and paragraphs [0024] and [0041], as seen in figure 5 there are some particles of the sample material (item 52) which are not dissolved, thereby forming a suspension, and as shown by the arrows, aspiration is occurring while there is the suspension).
Van Berkel fails to teach the extraction tool having a cutting tip and imparts a rotating cutting motion to the region of the biological material.
Bing teaches an extraction device which utilizes a rotating cutting head when it is brought into contact with the sample as it greatly increases the likelihood of successfully removing the sample from the array (Bing, page 4, lines 9-12).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have added a rotating cutting head to the device of Van Berkel because it would greatly increase the likelihood of successfully removing the sample from the array (Bing, page 4, lines 9-12).
Regarding claim 5, Van Berkel teaches wherein the liquid is dispensed at an interface between the region of biological material and the extraction tool (figure 5).
Regarding claim 6, Van Berkel teaches wherein the liquid is dispensed and aspirated simultaneously (paragraphs [0033] and [0036]).
Regarding claim 7, Van Berkel teaches wherein the liquid is dispensed and aspirated by the extraction tool (figure 5).
Regarding claims 8 and 9, modified Van Berkel, as described above, teaches all limitations of claim 1; however, modified Van Berkel, as described above fails to teach identifying a region of biological material further includes; obtaining a real time digital image of the biological sample; defining an area of interest on the digital image corresponding to the region of biological material, wherein movement of the biological sample is reflected by movement of the area of interest and/or the digital image to maintain position of the area of interest relative to the biological material; and wherein the biological sample is a series of biological sections, and wherein the area of interest is defined on one section corresponding to the region of biological material from a different section.
Bing teaches an extraction device which identifying a region of biological material further includes; obtaining a real time digital image of the biological sample (Bing, page 10, lines 5-13); defining an area of interest on the digital image corresponding to the region of biological material (Bing, page 10, lines 5-13), wherein movement of the biological sample is reflected by movement of the area of interest and/or the digital image to maintain position of the area of interest relative to the biological material (if the biological sample is moved, the image would also move accordingly); and wherein the biological sample is a series of biological sections (Bing, page 10, lines 5-13), and wherein the area of interest is defined on one section corresponding to the region of biological material from a different section (Bing, page 10, lines 5-13) which allows for the user to pick an area to excise and the device will move into position to remove the specified section (Bing, page 3, lines 21-30).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have used a real time digital image of the sample, define the area of the sample of a series of biological samples (as described above) because it would allow for the user to pick an area to excise and the device will move into position to remove the specified section (Bing, page 3, lines 21-30).
Regarding claim 10, Van Berkel teaches wherein the biological sample is disposed on a substantially planar surface (figure 4).
Regarding claims 11 and 12, Van Berkel teaches a method for selectively extracting biological material from a biological sample (paragraph [0020]), comprising: identifying a region of biological material to be extracted from a biological sample (paragraphs [0027]-[0029]); mechanically disrupting biological material from the identified region of biological material from the biological sample with an extraction tool (paragraph [0024, item 25); and recovering the disrupted biological material from the biological sample using a liquid (paragraph [0041]), wherein the liquid and the disrupted biological material form a suspension that is recovered from the biological sample (figure 5 and paragraphs [0024] and [0041], as seen in figure 5 there are some particles of the sample material (item 52) which are not dissolved, thereby forming a suspension, and as shown by the arrows, the sample is recovered while there is the suspension).
Van Berkel fails to teach the extraction tool having a cutting tip and is a milling machine.
Bing teaches an extraction device which utilizes a rotating cutting head when it is brought into contact with the sample as it greatly increases the likelihood of successfully removing the sample from the array (Bing, page 4, lines 9-12).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have added a rotating cutting head (milling machine) to the device of Van Berkel because it would greatly increase the likelihood of successfully removing the sample from the array (Bing, page 4, lines 9-12).
Regarding claims 13 and 14, modified Van Berkel, as described above, teaches all limitations of claim 11; however, modified Van Berkel, as described above fails to teach identifying a region of biological material further includes; obtaining a real time digital image of the biological sample; defining an area of interest on the digital image corresponding to the region of biological material, wherein movement of the biological sample is reflected by movement of the area of interest and/or the digital image to maintain position of the area of interest relative to the biological material; and wherein the biological sample is a series of biological sections, and wherein the area of interest is defined on one section corresponding to the region of biological material from a different section.
Bing teaches an extraction device which identifying a region of biological material further includes; obtaining a real time digital image of the biological sample (Bing, page 10, lines 5-13); defining an area of interest on the digital image corresponding to the region of biological material (Bing, page 10, lines 5-13), wherein movement of the biological sample is reflected by movement of the area of interest and/or the digital image to maintain position of the area of interest relative to the biological material (if the biological sample is moved, the image would also move accordingly); and wherein the biological sample is a series of biological sections (Bing, page 10, lines 5-13), and wherein the area of interest is defined on one section corresponding to the region of biological material from a different section (Bing, page 10, lines 5-13) which allows for the user to pick an area to excise and the device will move into position to remove the specified section (Bing, page 3, lines 21-30).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have used a real time digital image of the sample, define the area of the sample of a series of biological samples (as described above) because it would allow for the user to pick an area to excise and the device will move into position to remove the specified section (Bing, page 3, lines 21-30).
Regarding claim 15, Van Berkel teaches wherein the biological sample is disposed on a substantially planar surface (figure 4).
Regarding claim 18, Van Berkel teaches wherein the biological sample is a tissue sample (paragraph [0021]).
Claim 8 and 13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Haddad in view of DE 112008002511, hereinafter Kurtz.
Regarding claim 8, Haddad teaches all limitations of claim 1; however, Haddad fails to teach wherein identifying a region of biological material further includes; obtaining a real time digital image of the biological sample; defining an area of interest on the digital image corresponding to the region of biological material, wherein movement of the biological sample is reflected by movement of the area of interest and/or the digital image to maintain position of the area of interest relative to the biological material.
Kurtz teaches a method for cataract surgery in which wherein identifying a region of biological material further includes; obtaining a real time digital image of the biological sample (Kurtz, page 16, paragraph 3); defining an area of interest on the digital image corresponding to the region of biological material (Kurtz, page 16, paragraph 3), wherein movement of the biological sample is reflected by movement of the area of interest and/or the digital image to maintain position of the area of interest relative to the biological material (Kurtz, page 16, paragraph 3) so that the device can be controlled with precision and accuracy during the entire surgical intervention (Kurtz, page 16, paragraph 3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have obtained a real time digital image, defined and area and to maintain position of the area of interest because it would allow for the device can be controlled with precision and accuracy during the entire surgical intervention (Kurtz, page 16, paragraph 3).
Regarding claim 13, Haddad teaches all limitations of claim 11; however, Haddad fails to teach wherein identifying a region of biological material further includes; obtaining a real time digital image of the biological sample; defining an area of interest on the digital image corresponding to the region of biological material, wherein movement of the biological sample is reflected by movement of the area of interest and/or the digital image to maintain position of the area of interest relative to the biological material.
Kurtz teaches a method for cataract surgery in which wherein identifying a region of biological material further includes; obtaining a real time digital image of the biological sample (Kurtz, page 16, paragraph 3); defining an area of interest on the digital image corresponding to the region of biological material (Kurtz, page 16, paragraph 3), wherein movement of the biological sample is reflected by movement of the area of interest and/or the digital image to maintain position of the area of interest relative to the biological material (Kurtz, page 16, paragraph 3) so that the device can be controlled with precision and accuracy during the entire surgical intervention (Kurtz, page 16, paragraph 3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have obtained a real time digital image, defined and area and to maintain position of the area of interest because it would allow for the device can be controlled with precision and accuracy during the entire surgical intervention (Kurtz, page 16, paragraph 3).
Claims 16 and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Van Berkel and Bing as applied to claim 15 above, and further in view of United States Application Publication No. 2006/0148063, hereinafter Fauzzi.
Regarding claims 16 and 17, Van Berkel and Bing teach all limitations of claim 15; however, they fail to teach the substantially plana surface is a microscope slide.
Fauzzi teaches a method of preparing a biological sample in which the biological sample is presented on a microscope slide and fixed to the slide with paraffin wax so that the samples can be preserved on the microscope slide (Fauzzi, paragraph [0011]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have utilized a microscope slide as the substantially planar surface because it would allow the biological sample to have paraffin wax added and to be preserved on the microscope slide (Fauzzi, paragraph [0011]).
Claims 19 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Van Berkel and Bing as applied to claim 18 above, and further in view of Fauzzi.
Regarding claims 19 and 20, Van Berkel and Bing teach all limitations of claim 18; however, they fail to teach the tissue sample is chemically fixed and embedded in paraffin wax.
Fauzzi teaches a method of preparing a biological sample in which the biological sample is presented on a microscope slide and fixed to the slide with paraffin wax so that the samples can be preserved on the microscope slide (Fauzzi, paragraph [0011]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have utilized fixed the biological sample and embedded it in paraffin wax because it would allow the biological sample to be preserved on the microscope slide (Fauzzi, paragraph [0011]).
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument that Van Berkel does not teach or suggest that the liquid and disrupted biological material form a suspension is not found persuasive. As can be see in figure 5 and discussed in paragraph [0032] of van Berkel, the material (sample) is present in the fluid as pieces of the material which are not fully dissolved and therefore as shown, forms a suspension. Additionally, as shown in figure 5, with the arrows, the aspiration/recovery of the liquid and sample is occurring while the particles of the sample are not fully dissolved in the solvent. As such, van Berkel teaches that the biological material forms a suspension in the fluid and is aspirated as a suspension. The claim does not specify at what point the sample and the fluid forms the suspension and therefore, as long as there is a point at which the sample and fluid form a suspension, van Berkel would read on the prior art. Additionally, the applicant states that a suspension implies a heterogenous mixture which solid particles are dispersed in a fluid but doesn’t dissolve, however, based upon the definition of a suspension, there is nothing which states that the solid particles cannot dissolve over time. The only thing required for a suspension is that minute particles which are dispersed in a fluid. As seen in figure 5, there is a point at which the sample is formed as minute particles (item 52) which are dispersed in the fluid. The fact that the sample is dissolved when the mixture reaches the mass spectrometer, doesn’t change the fact that as shown in figure 5, there is a point at which the sample forms a suspension and is aspirated/recovered as a suspension.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796