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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract does not provide for a concise statement of the technical disclosure of the patent and what is new in the art to which the invention pertains. The abstract employs legal phraseology such as the term “comprising”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the press plate (claim 158) , base (claims 160-161), solid reactive material in the channel (claims 162-63), the lid (claim 164), automated liquid handler and computer (claim 168) that are not labeled nor referenced by any reference numeral in the drawings/specification must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that although the apparatus claims mention liquid reagents, an automatic liquid handler (and elements of such, claim 166), and liquid (claims 168-175), and reservoir (claim 169), none of such are positively claimed as elements of the invention. All of such are materials and/or articles intended to be, can be worked upon, and/or used with the apparatus. However, none of such structurally define the claimed apparatus. It is noted that the “for iterative exchange…” clause of the preamble of claim 156 is directed to intended use. The apparatus is not required to be used in any process at all, including with any unclaimed materials or articles including that as may be intended by applicant. The apparatus is not structurally defined by any process steps, possible uses.
It is noted that the phrase “at least one” only requires one and the phrase “at least two” only requires two.
As to claim 159, it is noted that the phrase “is inserted into…” phrase implies a process step.
It is noted that the terms “reactive material” and “biological sample” recited in the claims are broad and are not required to be any specific material, chemical, or substance.
Claim Rejections - 35 USC § 112
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 156-175 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.
As to claim 156, it is unclear what is structurally meant, required by the phrase “semi-open” because the claim does not define such in the claim. There is no relative basis (definitive measurable comparative degree, amount of opening) provided for in the claim to indicate what is structural considered as “semi-open”. It is noted the reaction chamber comprises channel openings. Therefore the reaction chamber is open.
As to claim 156, it is unclear what/which semi-open reaction chamber(s) is/are being reference by the phrase “each semi-open reaction chamber”, if such are the same or different from the “at least on semi-open reaction chamber” because the claim does not recite such.
Claim 156 recites the limitation "the same spacing strips" in line 5. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear what is the nexus of such to the prior “at least two parallel strips” because the claim does not clearly recite such. Furthermore, it is unclear what side of what is being referenced in the phrase “on a side”.
As to claim 156, it is unclear what is structurally considered an “overhang” (if the solid support has a dimension (length, width, etc.) that extends over and further than a dimension of the solid planar cover or vice versa) because such is not defined in the claim.
As to claim 156, in (b) it is unclear what/which reaction chamber is being referenced by the phrase “the reaction chamber” because the claim does not clearly indicate such. It is noted that the claim previously recites “at least one semi-open reaction chamber”.
The term “about 5-85 degrees” in claim 156 is a relative term which renders the claim indefinite. The term “about 5-85 degrees” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no indication what variations from the recited range value, values that are not 5-85 degrees are considered by applicant as “about 5-85 degrees” because the claim does not provide for such. What values that may be considered as “about 5-85 degrees” to one person may not be considered as such to another and vice versa.
Furthermore, it is noted that the gravity vector of Earth is not a structural element of the apparatus. The incline is not claimed relative to any positively claimed structure of the apparatus. How the apparatus is oriented relative to a surface of the planet Earth is a choice, not a requirement. Whether not the channel is inclined at the recited degree range relative to earth is a choice not a requirement. The entire apparatus, including the channel can be oriented such that the channel is arranged at any angle relative to the gravity vector of Earth as one so desires. Therefore, it is unclear what is further structurally required by the “wherein” clause of (b).
Dependent claims 157-175 are rejected via dependency upon a rejected claim.
The terms “differential adhesive”, “a high-tack side”, and “a low-tack side” in claim 157 are relative terms which renders the claim indefinite. The terms “differential adhesive”, “a high-tack side”, and “a low-tack side” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no indication as to what is required of an adhesive to be considered “differential”. Furthermore, it is unclear what sides of what are being referenced; what comprises “a high-tack side”, and “a low-tack side” and what is structurally required of a side to be considered as “a high-tack side” and “a low-tack side”.
As to claim 158, it is noted that the phrase “is added…” implies a method step if the press plate is located on the solid planar cover, then the claim should clearly recite such. Furthermore, it is unclear what is structurally meant, required by the “which helps…” clause because help is not defined in the claim. If there is a seal that exists then, the claim should clearly recite such.
Claim 158 recites the limitation "the contact between the spacing strips, …" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Furthermore, it is unclear what/which spacing strips are being referenced in the phrase because claim 1 previously recites “at least two parallel spacing strips”.
Claims 160-161 recite the limitation " the base of the open-top container". There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear which/what open-top container is being referenced in the claims because claim 159 recites at least one open-top container.
As to claim 163, it is unclear what is the structural nexus, connectivity of the reactive material to the previously positively claimed elements of claim 156 because the claim does not provide for such.
Claim 164 recites the limitation "the top of the at least one open-top container". There is insufficient antecedent basis for this limitation in the claim.
It is unclear what is further structurally required by claim 166 because the claim does not provide for any further structural element of the apparatus nor any previously positively claimed structural element. Instead the claim is directed to what is possible relative to an unclaimed automatic liquid handler that is not structure of the claimed apparatus. The apparatus can be inserted into anything that has dimensions that allows for such. Here, it is noted that there are no dimensions provided for of the apparatus to indicate what would be the required dimensions of any further structure such that the apparatus can be inserted into such structure. Furthermore, it is noted that the automated liquid handler is not defined as comprising any specific structure, including any structure than can provide for any automation. Therefore, it is unclear what is structural required to be considered as an automatic liquid handler. Also applicable to claim 168.
As to claim 167, it is noted that the dispensing is not required to be performed by any specific structure nor is any specific structure required to be employed in such dispensing.
As to claim 168, it is unclear what is structurally required to define “an automatic liquid handler” because such is not structurally defined in the claim. See also rejection of claim 167. Although not positively claimed ,it is unclear what is the nexus of “a liquid” to the liquid reagents recited in claim 156 because the claim does not provide for such. (See also claims 170-175).
As to claim 170, it is unclear what is “a plurality of liquid”. The phrase appears to be grammatically incorrect.
It is unclear what is further structurally required by claims 171-175 because the claims are directed to the unclaimed liquid that is not a structural element of the system of claim 168 nor apparatus of claim 156. Furthermore, the intended use of such liquid as recited in the “for…” clause of claim 171 does not further structurally define the system of claim 168. No staining is required to be performed.
As to claim 175, it is unclear what is “ISH” and “FISH” because such are not defined in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 156, 158, 162-163, and 166-167 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Duerr, "lmmunohistochemistry" (cited by applicant).
Duerr teaches an apparatus for iterative exchange of liquid reagents (apparatus shown in Figure at top of page 19, apparatus can be used for iterative exchange of liquid reagents as it comprises a reaction chamber defined between two glass plates, page 18, section 2.16.2, step 2: '2. For each gel, assemble 1 large and 1 small glass plate and 2-4 spacers as follows.'), the apparatus comprising:
(a) at least one semi-open reaction chamber (reaction chamber defined by two glass plates with spacers between them, see figure on top of page 19, chamber is open at top and bottom), each semi-open reaction chamber comprising a solid planar cover, at least two parallel spacing strips, and a solid planar support (the larger glass plate defines a solid planar support, the two spacers define parallel spacing strips, and the smaller glass plate defines a solid planar cover, see Figure at top of page 19);
wherein the at least two parallel spacing strips are affixed on one side to the solid planar support (Figure on top of page 19, spacer strips are affixed between solid planar support and solid planar cover);
and the solid planar cover is affixed to the same spacing strips on a side opposite the solid planar support (Figure on top of page 19, spacer strips are affixed between solid planar support and solid planar cover), thereby forming a channel comprising a first opening at a first end of the channel and a second opening at a second end of the channel (a channel is defined between the top and bottom of the glass plates, having a first opening at the top and second opening at the bottom, see figure at top of page 19); wherein there is an overhang between the solid planar support and the solid planar cover (See Box VIII) (figure on top of page 19, the larger glass plate defining the planar support is longer than the smaller glass plate defining the planar cover, thereby creating an overhang when the chamber is placed on a rack as shown in the leftmost image);
(b) at least one rack connected to the reaction chamber (rack shown on right side of rightmost image supporting chamber, figure on top of page 19), wherein the channel of at least one of the at least one semi-open reaction chamber is at an incline of about 5-85 degrees with respect to the gravity vector of the Earth, with the first opening positioned higher than the second opening (Figure on top of page 19, the rightmost image shows the chamber being inclined approximately 5 degrees relative to a gravity vector extending from top to bottom, first opening is higher than the second).
As to claim 158, as shown in the Figures the device includes a further plate structure (press plate) on top of the cover.
As to claims 163-164 and 167, various reactive materials can be dispensed to and affixed to the planar support. See the entire reference including the various procedures and protocols described throughout the refence such as that disclosed in the text under the figures referenced above.
The automatic liquid handler of claim 166 is not a structural element of the apparatus of claim 156. See remarks above.
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.
Claim(s) 168-175 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duerr as applied above, and further in view of Favuzzi et al, US 2005/0064535.
Duerr does not disclose a system comprising an automated liquid handler and a computer.
Favuzzi discloses an automated slide treatment device comprising a robot arm 20 may therefore position the probe 10 above all reagent vials 3 as well as above all the microscope slides 7, and may further operate the probe 10 (automated liquid handler that can siphon and dispense liquid) to aspirate portions of reagent contained in any of the vials 3, to transfer the portion of reagent and apply it to any of the slides 7 in order to provide a selected staining or treatment of the sample on each slide 7. By use of suitable control means e.g. a computer (not shown) having the appropriate software and input data for the purpose, this staining apparatus 1 may be able to automatically staining or treating samples requiring different staining or treatment reagents and processes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to employ an automated system with the apparatus of Duerr to provide for automated operation of performing protocols and procedures including aspirating liquid and dispensing liquids to the apparatus of Duerr as taught by Favuzzi.
The liquid of claims 171-175 are not positively claimed as structural elements of the invention.
Allowable Subject Matter
Claims 157, 159-161, and 164-165 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Duerr does not teach nor fairly suggests the structural elements provided for in claims 157, 159-161, and 164-165.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. OEI; TING PAU et al.; CHOU; Stephen et al.; Reinhardt; Kurt et al.; EINSLE; Xaver; KAFFKA; Christian et al.; GUO; James et al.; Machida; Yuuichi et al.; HONJO; Tsutomu; BUI; XUAN S. et al.; Richards; William et al.; Chu; Wei-Sing; Yoder; Karl et al.; Yamashita; Tatsumaro et al.; Favuzzi, John et al.; Sillman, Debra A.; Ljungmann; Torstein; Stapleton; Marilyn J.; Bowman; David J. et al.; and Blatt; Joel M. et al. disclose rack, holders, or support devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798