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 .
Information Disclosure Statement
No IDS has been filed in this application. Applicant is reminded that each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the U.S. Patent and Trademark Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability. 37 CFR 1.56.
Response to Arguments
Applicant’s arguments filed 07/01/2026 have been fully considered but they are not persuasive.
In response to applicant’s argument that Angros fails to disclose or teach the coater module horizontally moves along the non-porous substrate, the examiner disagrees. Angros discloses in paragraph [0170] wherein during operation the reagent strip 10 is moved in a direction (horizontal) toward the rear end 128 of the reagent strip support device 116 as shown in Fig. 23 reproduced below. The reagent strip 10 may be advanced manually or automatically via a pulling or pushing device, including rollers or a track which incrementally advances the reagent strip 10 as instructed by the microprocessor. Therefore, Angros discloses a coater module maintain a preset height for horizontally moving along a surface of the non- porous substrate.
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As to forming a liquid bridge of the target liquid is laterally extended to coat on a surface of the non- porous substrate, it appears that applicant is arguing about how Angros operates (i.e., forming a liquid bridge ). However, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114. Thus, a method of operation does not patentably distinguish an apparatus from the prior art. It is also noted that a material or article (i.e., a target liquid) worked upon does not further limit an apparatus claim. Said limitation does not differentiate apparatus claims from prior art. Further, it has been held that inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims. See MPEP § 2115.
In response to applicant’s argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., In the reaction platform, each tissue section was only coated with a layer of thin-film diluted anti-CD8a antibody solution (from 0.02 to 1 µg/mL with volume of 0.02 mL) measuring some tens of micrometers in thickness and then statically laid on the tissue section for 6 mins...) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See MPEP § 2145 VI.
In response to applicant’s argument that claim 1 has an unexpected advantage, the examiner disagrees. A demonstration of unexpected results is typically indicated through a side-by-side comparison of the instant invention with the closest prior art. There is no documented evidence to suggest that this improvement is truly unexpected. The evidence relied upon should establish that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. See MPEP 716.02(b). Moreover, arguments presented by the applicant cannot take the place of evidence in the record. See MPEP § 716.01(c) (II).
In response to applicant’s argument that Angros does not specifically state that a temperature measuring device is provided on the dispensing plunger 154, nor does it provide a heating element on the dispensing plunger 154. Therefore, a person having ordinary skill in the art of the present application, when referring to the disclosure of Angros, would have no motivation to provide the temperature control device of the present application on the dispensing plunger in order to increase the temperature of the dispensing plunger, the examiner disagrees. As an initial mater, the examiner did not equate the dispensing plunger 154 to the claimed coater module. The previous Office Action clearly indicates that the coated module is mapped to the reagent strip 10 and reagent strip support device 116, not dispensing plunger 154 (at page 3 of the Non-Final Rejection dated 04/01/2026). Since applicant’s argument does not accurately address the rejection of record, the response regarding the dispensing plunger 154 is moot. Further, the examiner maintains that Angros suggests the limitations of claim 8, since Angros discloses “The reaction module 110 may further comprise a thermocouple or other temperature measuring device for measuring temperatures of the slide or other components therein” [0170]. Therefore, Angros meets the claim.
In response to applicant’s argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., controlling the temperature of the coater to increase the temperature of a target liquid and accelerate biochemical reactions) measuring some tens of micrometers in thickness and then statically laid on the tissue section for 6 mins...) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See MPEP § 2145 VI.
In response to applicant’s argument that claim 8 has an unexpected advantage, the examiner disagrees. A demonstration of unexpected results is typically indicated through a side-by-side comparison of the instant invention with the closest prior art. There is no documented evidence to suggest that this improvement is truly unexpected. The evidence relied upon should establish that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. See MPEP 716.02(b). Moreover, arguments presented by the applicant cannot take the place of evidence in the record. See MPEP § 716.01(c) (II).
In response to applicant’s argument regarding claim 7, the examiner disagrees. As an initial matter, it is noted that applicant has fabricated a motivation (i.e., Accordingly, Angros has clearly disclosed the cleaning method of the reaction module of the invention, and is already capable of achieving its expected purpose and effects. A person having ordinary skill in the art would have no motivation to modify the existing cleaning mechanism of Angros and combine the shaker plate of Dadgar, which is used for causing agitation of a cell suspension, to achieve the present invention.) that does not exist in the previous rejection of record. Further, applicant has provided arguments against that motivation. Since applicant’s argument does not actually address the rejection of record (at page 6 of the Non-Final Rejection dated 04/01/2026), the response regarding the manufactured motivation to combine of Angros and Dadgar is moot. The examiner maintains that Angros in view of Dadgar discloses the limitations of claim 7 for reasons discussed in the previous Office Action.
In response to applicant’s argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., achieving short-time in-situ washing and simultaneously optimizing signal quality by way of a vibrator) measuring some tens of micrometers in thickness and then statically laid on the tissue section for 6 mins...) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See MPEP § 2145 VI.
In response to applicant’s argument that claim 7 has an unexpected advantage, the examiner disagrees. A demonstration of unexpected results is typically indicated through a side-by-side comparison of the instant invention with the closest prior art. There is no documented evidence to suggest that this improvement is truly unexpected. The evidence relied upon should establish that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. See MPEP 716.02(b). Moreover, arguments presented by the applicant cannot take the place of evidence in the record. See MPEP § 716.01(c) (II).
Claim Rejections - 35 USC § 102
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.
Claims 1-6 and 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Angros et al. (hereinafter Angros) US 2006/0275889.
Regarding claim 1, Angros discloses a machine body ( reaction module 110 and reaction compartment 112) with a bottom plate (slide support element 114) for placing a non-porous substrate (slide 140); and a coater module (reagent strip 10 and reagent strip support device 116) provided above the machine body and capable of maintaining a preset height for horizontally moving along a surface of the non-porous substrate (wherein during operation the reagent strip 10 is moved in a direction (horizontal) toward the rear end 128 of the reagent strip support device 116 as shown in Fig. 23 reproduced below. The reagent strip 10 may be advanced manually or automatically via a pulling or pushing device, including rollers or a track which incrementally advances the reagent strip 10 as instructed by the microprocessor. As shown in at least Fig. 23 reproduced below and discussed in [0170]), wherein the coater module has one or more slits (The reaction module 110 also comprises a dispenser plunger 154 (also referred to herein as a dispensing element), which has a dispensing canal 156 therein for allowing passage of another reagent or solution therethrough preferably from a remote source. [0170]; and The reagent strip support device 116 preferably has an injector port orifice 124 for receiving at least a portion of an injector nozzle 46 from a reagent container 14 of the reagent strip 10 during use thereof. [0172]), a target liquid can be directly injected or sucked in through the slit from an exterior of the coater module [0308 and 0319], and the target liquid is coated on a surface of the non-porous substrate when the coater module moves along the non-porous substrate (Also before operation the reagent strip 10 (or any other reagent strip described or enabled herein) is inserted into the reagent strip support device 116, for example, inserting the first end 22 of the reagent strip 10 into the front end of 126 of the reagent strip support device 116, wherein during operation the reagent strip 10 is moved in a direction toward the rear end 128 of the reagent strip support device 116. [0170]), and wherein the surface of the non-porous substrate has a target to be coated, discussed in [0104 and 0129] and shown in at least Figs. 24A, 25A, 26A, 27A, 28 and 29. Also see whole document.
As to forming a liquid bridge of the target liquid that is laterally extended to coat on a surface of the non-porous substrate when the coater module horizontally moves, it appears that applicant is arguing about how Angros operates (i.e., forming a liquid bridge). However, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114. Thus, a method of operation does not patentably distinguish an apparatus from the prior art. It is also noted that a material or article (i.e., a target liquid) worked upon does not further limit an apparatus claim. Said limitation does not differentiate apparatus claims from prior art. Further, it has been held that inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims. See MPEP § 2115.
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Regarding claim 2, Angros discloses wherein the coater module is connected to a cleaning solution storage tank (reagent containers 14, [0139]; and rinse solution reservoir (not shown) [0172]).
Regarding claim 3, Angros discloses wherein the coater module has a slit (rinse port apertures 32) as a first cleaning solution flow channel [0146].
Regarding claim 4, Angros discloses wherein the bottom plate (slide support element 114) is indirectly connected to a cleaning solution storage tank (rinse solution reservoir (not shown) [0172]).
Regarding claim 5, Angros discloses wherein the bottom plate is provided with a second cleaning solution flow channel (reagent conduit 122) [0170 and 0172].
Regarding claim 6, Angros discloses a waste liquid storage tank, and the waste liquid storage tank is connected to the bottom plate for liquid discharge (The slide support element 114 also preferably has a drainage port 146 for receiving and draining reagents and waste liquids from the reaction compartment 112. In a preferred embodiment the apparatus of the present invention has a waste container (not shown) which can be connected to all the reaction modules 110 by a fitting that can join multiple tubes or conduits. 0170 and 0187]). Also see [0172],
Regarding claim 9, Angros discloses a temperature control device provided adjacent the bottom plate (The slide support element 114 comprises a heating element 136 upon which a slide 140 is placed. [0169]). Also see [0119].
Regarding claim 10, Angros discloses wherein the coater module is arranged with multiple non-porous substrates to form one or more slits [0104, 0118 and 0126].
Regarding claim 11, the staining apparatus of Angros is capable of being used for immunostaining, immunohistochemical staining, immunofluorescent staining, or cell imprint staining. See abstract and [0104 and 0182]
Regarding claim 12, Angros discloses wherein the non-porous substrate is a glass slide, plastic, non-metal or metal [0123, 0169 and 0185].
Regarding claim 13, Angros discloses wherein the target liquid comprises antibodies, molecular probes, drugs, or cells [0105 and 0214].
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.
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Angros US 2006/0275889 as applied to claims 1-6 and 9-13 above.
Regarding claim 8, Angros discloses further comprising a temperature control device (The reaction module 110 may further comprise a thermocouple or other temperature measuring device for measuring temperatures of the slide or other components therein. [0170]).
However, Angros does not expressly state that the temperature control device is provided on one or both sides of the coater.
Absent unexpected results, it would have been prima facie obvious to one of ordinary skill in the art to provide the temperature control device on one or both sides of the coater, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP §2144.04 (VI-C).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Angros US 2006/0275889 as applied to claims 1-6 and 8-13 above, and further in view of Dadgar et al. (hereinafter Dadgar) US 2020/0332243.
Regarding claim 7, Angros does not disclose wherein the bottom plate is further provided with an oscillator.
Dadgar discloses a cell preparation device comprising a bottom plate (platform 102) is further provided with a shaker plate 304 mounted on a top surface of the platform [0078-0079].
The shaker plate of Dadgar has been interpreted as a functional equivalent to that of an oscillator.
Absent unexpected results, it would have been prima facie obvious to one of ordinary skill in the art to modify Angros with the shaker plate as taught by Dadgar in order to ensure constant gentle mixing of the samples. This is crucial for reducing non-specific antibody binding and achieving optimal results.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Wednesday 08:00-18:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached on 571-272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796
