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 .
Election/Restrictions
Applicant's election with traverse of Group IV, which consists of claims 58-60, in the reply filed on 06/08/2026 is acknowledged. No arguments were made regarding the traversal. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the requirement is still deemed proper and is therefore made FINAL.
Specification
The use of the term 'Diff Quik [0004]', which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informality:
There are two periods at the end of paragraph 0014.
Appropriate correction is required.
Drawings
The drawings are objected to because Fig 3A and Fig 3B seem to be cut off. 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
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitations are: ‘sample handling system' in claim 60 and ‘control system’ in claim 60.
The specification defines the ‘sample handing system’ to include a sample transfer mechanism, a sample smearing mechanism, and a sample movement mechanism (Specification, para 0017). Under the 3-prong analysis, the limitation should be interpreted under 112(f) for the following reasons:
The claim limitation uses the term ‘system’ which is a generic place holder for the term ‘means’.
The generic placeholder is modified by functional language. The functional language is ‘to receive a sample cartridge containing a sample’.
The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. See MPEP §2181(I). The term "system" is not modified by sufficient structure.
The specification defines the ‘control system’ to be purpose-built hardware [Specification, para 00124]. Under the 3-prong analysis, the limitation should be interpreted under 112(f) for the following reasons:
The claim limitation uses the term ‘system’ which is a generic place holder for the term ‘means’.
The generic placeholder is modified by functional language. The functional language is ‘to cause the sample handling system to manipulate the sample cartridge to perform sample processing steps without the sample contacting the sample transfer mechanism, the sample smearing mechanism, a sample orientation mechanism, or the sample movement mechanism.’
The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. See MPEP §2181(I). The term "system" is not modified by sufficient structure.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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.
Claims 58 and 59 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Hayama (US 20140092382 A1).
Regarding Claim 58, Hayama teaches a sample processing system (para 0008, “specimen testing system”) comprising:
a sample handling system (para 0007, “specimen transporter”) including:
a sample transfer mechanism (para 0060),
a sample smearing mechanism (para 0037, “specimen creating apparatus”), and
a sample movement mechanism (para 0092, “rack transport mechanism”);
a fluid distribution system (para 0085); and
a control system (para 0040, “control section”).
Regarding Claim 59, Hayama teaches the sample processing system (para 0008, “specimen testing system”), further comprising: at least one imaging device (para 0007, “specimen imaging apparatus”).
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 60 is rejected under 35 U.S.C. 103 as being unpatentable over Hayama (US 20140092382 A1) as applied to claim 58 above, and further in view of Holmes et al. (US 20160069918 A1).
Regarding claim 60, Hayama teaches a sample processing system of claim 58. Hayama teaches a sample handling system (para 0007, “specimen transporter”) and a control system (para 0040, “control section”).
Hayama does not teach the sample handling system being configured to receive a sample cartridge containing a sample, and the control system being configured to cause the sample handling system to manipulate the sample cartridge to perform sample processing steps without the sample contacting the sample transfer mechanism, the sample smearing mechanism, a sample orientation mechanism, or the sample movement mechanism.
However, Holmes teaches systems and methods for processing a biological sample (Abstract). Holmes teaches sample handling system being configured to receive a sample cartridge containing a sample (para 0007). Holmes also teaches various methods of transport the cartridge with the sample such as a transport assembly (para 0049). It is interpreted the transport assembly could be interpreted as is a “sample transfer mechanism”. It can be seen in Figure 2, the transport assembly is touching the sample-containing cartridges and does not touch the sample (para 0049). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teaching of Hayama with cartridges to contain the sample in which the sample does not come in contact with the sample transfer mechanism as taught by Holmes for the benefit of cartridges having the ability to be preloaded with reagents-containing vessels for performing assays (para 0044) and minimize contamination of the sample.
Conclusion
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/H.R.B./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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