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.
Information Disclosure Statement
The information disclosure statement dated 6/23/2023 has been considered and made of record.
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.
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 1-22 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.
In claims 1, 11, 21 and 22, recitation of “an optical block” is considered to be indefinite because it is not clear from the current claim language whether or not the “optical block” is a positively recited element of the claimed device. Currently, the claim recites “heating block alignment holes for removable attachment of an optical block”; however, while the claim further describes the optical block in detail, the claim is devoid of any language that implies that the optical block is a positively recited element of the claimed “A limited well thermal cycling device”. As result, the claims will be interpreted as though the “optical block” is not a positively recited element of the claimed device. Clarification and/or correction is requested.
In claim 1, “the outer emission orifice” and “inner emission orifice” of the optical block lacks antecedent basis. Note: claim 1 is devoid of any previous recitation of an inner or an outer “emission orifice” associated with the optical block. Clarification and/or correction is requested.
In claim 11, the second recitation of “heating block alignment holes” is considered indefinite because is it not clear if these are the same holes as previously recited or additional holes. Clarification and/or correction is requested.
In claim 11, “the first outer emission orifice”, “first inner emission orifice”, “the second outer emission orifice” and “second inner emission orifice” of the optical block lack antecedent basis. Note: claim 11 is devoid of any previous recitation of an inner or an outer “emission orifice” associated with the optical block. Clarification and/or correction is requested.
In claim 19, “the first reaction well” and “the second reaction well” lack antecedent basis. Note: claim 19 depends from claim 1 rather than claim 11. Clarification and/or correction is requested.
In claim 22, “the outer emission orifice” and “inner emission orifice” of the optical block lacks antecedent basis. Note: claim 22 is devoid of any previous recitation of an inner or an outer “emission orifice” associated with the optical block. Clarification and/or correction is requested.
Claims 2-10, 12-18 and 20 are considered indefinite because they depend from indefinite claims and fail to cure the deficiencies of the claims from which they depend.
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.
Claims 1, 4-11 and 14-22 are rejected under 35 U.S.C. 103 as being unpatentable over Oommen et al. (US 2017/0115222) in view of Courtney (US 2015/0233828).
With respect to claim 1, the reference of Oommen et al. discloses:
A limited well thermal cycling device (Figs. 1-9) for preparation of a biological sample for amplification and detection of an analyte, the limited well thermal cycling device comprising:
a heating block (100) configured for preparation of the biological sample and amplification of the analyte, the heating block comprising:
a sample well (101) having a bottom (Fig. 2B and 8B) configured for receiving and preparing the biological sample for amplification and detection, the sample well extending from a top of a heating block base;
a reaction well (101) having a bottom (Fig. 2B and 8B) configured for receiving and amplifying an analyte of the prepared biological sample for detection, the reaction well extending from the top of the heating block base, wherein
the reaction well has an excitation orifice (102) and an emission orifice (103), where the excitation orifice and emission orifice are in 90 degree alignment; and
heating block alignment holes (202), the heating block alignment holes on the top of the heating block base, wherein the heating block alignment holes would be structurally capable of being used for removable attachment of an optical block to the heating block base; the optical block configured for detecting the analyte of the amplified and prepared biological sample, wherein the optical block is in removable attachment with the heating block, the optical block comprising
an inner excitation orifice and an outer excitation orifice, the inner excitation orifice having a smaller diameter than the outer excitation orifice where the inner and outer excitation orifice are in continuing alignment through a central portion of the optical block, wherein a center of the inner and outer excitation orifice is in linear alignment with a center of the reaction well excitation orifice; an LED board having an LED, the LED board in removable attachment with the optical block where the LED is received by the outer excitation orifice; a photodiode board having a photodiode, the photodiode board in removable attachment with the optical block where the photodiode is received by the outer emission orifice; an excitation filter, the excitation filter received by a ledge of the outer excitation orifice, the ledge formed by the continuing alignment between the inner and outer excitation orifice; an emission filter, the emission filter received by a ledge of the outer emission orifice, the ledge formed by the continuing alignment between the inner and outer emission orifice; and
a heating element (404) (¶[0044]) in heating communication with the heating block to provide heat transfer to the sample well and reaction well.
Note: As discussed in the rejection of claim 1 under 35 USC 112(b), the optical block is not considered to be a positively recited structure of the claimed device of claim 1.
Claim 1 first differs by reciting that the sample and reaction wells have flat bottoms.
While the reference of Oommen et al. specifically discloses wells with tapered bottoms (Figs. 2B and 8B), the reference also discloses that the wells (101) may be of any shape and diameter compatible with sample retention (¶[0042]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to determine the optimal well shape based merely on the specifics of the sample holder intended to be used within the device while maintaining the detection and temperature control of the sample within the thermal cycling device.
Additionally, while the reference of Oommen et al. discloses that the excitation and emission orifices are provided in 90 degree alignment (¶[0023] and [0043]), the reference is silent with respect to a third orifice with the intended use of cooling.
The reference of Courtney discloses that it is known in the art to provide a heating block (86) sample well (32) with a plurality of orifices (bores)(¶[0057) to allow additional optical interfacing with the sample container.
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide the wells of the reference of Oommen et al. with additional orifices for the known and expected result of allowing additional optical interfacing with the sample container positioned within the well. While the additional orifice is not specifically disclosed as a cooling orifice, the presence of the additional orifice as discussed above would be structurally capable of being used as a cooling orifice.
With respect to claim 4, the optical block has not been positively recited as an element of the claimed device. As result, the device of the modified primary reference would be structurally capable of being used with an optical block with orifices of the claimed diameters.
With respect to claim 5, the reference of Oommen et al. discloses the use of orifices in the heating block with diameters between 0.5 mm and 3.0 mm. (¶[0030]-[0032]).
With respect to claim 6, the reference of Oommen et al. disclose that the heating block can be made of aluminum (¶[0042]). Use of anodized aluminum would have been desirable to protect the block from corrosion.
With respect to claims 7 and 8, the optical block has not been positively recited as an element of the claimed device. As result, the device of the modified primary reference would be structurally capable of being used with an optical block made with the materials recited in claims 7 and 8.
With respect to claims 9 and 10, in the absence of a showing of unexpected results, the diameter and spacing of the wells would have been well within the purview of one having ordinary skill in the art while considering design factors such as the size of the sample vessels to be used in the system while maintaining optimization of the system.
With respect to claim 11, the reference of Oommen et al. discloses:
A limited well thermal cycling device (Figs. 1-9) for preparation of a biological sample for amplification and detection of an analyte, the limited well thermal cycling device comprising:
a heating block (100) configured for preparation of the biological sample and amplification of the analyte, the heating block comprising:
a sample well (101) having a bottom (Fig. 2B and 8B) configured for receiving and preparing the biological sample for amplification and detection, the sample well extending from a top of a heating block base;
a first reaction well (101) having a bottom (Fig. 2B and 8B) configured for receiving and amplifying an analyte of the prepared biological sample for detection, the reaction well extending from the top of the heating block base, wherein
the first reaction well has a first excitation orifice (102) and a first emission orifice (103), where the first excitation orifice and first emission orifice are in 90 degree alignment; and
heating block alignment holes (202), the heating block alignment holes on the top of the heating block base, wherein the heating block alignment holes would be structurally capable of being used for removable attachment of an optical block to the heating block base; the optical block configured for detecting the first and second analytes of the amplified and prepared biological sample, wherein the optical block is in removable attachment with the heating block, the optical block comprising
a first inner excitation orifice and a first outer excitation orifice, the first inner excitation orifice having a smaller diameter than the first outer excitation orifice where the first inner and outer excitation orifice are in continuing alignment through a central portion of the optical block, wherein a center of the first inner and outer excitation orifice is in linear alignment with a center of the first reaction well excitation orifice;
a second inner excitation orifice and a second outer excitation orifice, the second inner excitation orifice having a smaller diameter than the second outer excitation orifice where the second inner and outer excitation orifice are in continuing alignment through the central portion of the optical block, wherein a center of the second inner and outer excitation orifice is in linear alignment with a center of the second reaction well excitation orifice;
an LED board having a first and a second LED, the LED board in removable attachment with the optical block where the first LED is received by the first outer excitation orifice and the second LED is received by the second outer excitation orifice;
a photodiode board having a first and a second photodiode, the photodiode board in removable attachment with the optical block where the first photodiode is received by the first outer emission orifice and the second photodiode is received by the second outer emission orifice;
a first excitation filter, the first excitation filter received by a ledge of the first outer excitation orifice, the ledge formed by the continuing alignment between the first inner and first outer excitation orifice;
a second excitation filter, the second excitation filter received by a ledge of the second outer excitation orifice, the ledge formed by the continuing alignment between the second inner and second outer excitation orifice;
a first emission filter, the first emission filter received by a ledge of the first outer emission orifice, the ledge formed by the continuing alignment between the first inner and first outer emission orifice;
a second emission filter, the second emission filter received by a ledge of the second outer emission orifice, the ledge formed by the continuing alignment between the second inner and second outer emission orifice;
a second reaction well having a flat bottom configured for receiving and amplifying a second analyte of the prepared biological sample for detection, the second reaction well extending from the top of the heating block base, wherein the second reaction well has a second excitation orifice, and a second emission orifice, where the second excitation orifice and second emission orifice are in 90 degree alignment; and
a heating element (404) (¶[0044]) in heating communication with the heating block to provide heat transfer to the sample well and reaction well.
Note: As discussed in the rejection of claim 11 under 35 USC 112(b), the optical block is not considered to be a positively recited structure of the claimed device of claim 11.
Claim 11 first differs by reciting that the sample and reaction wells have flat bottoms.
While the reference of Oommen et al. specifically discloses wells with tapered bottoms (Figs. 2B and 8B), the reference also discloses that the wells (101) may be of any shape and diameter compatible with sample retention (¶[0042]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to determine the optimal well shape based merely on the specifics of the sample holder intended to be used within the device while maintaining the detection and temperature control of the sample within the thermal cycling device.
Additionally, while the reference of Oommen et al. discloses that the excitation and emission orifices are provided in 90 degree alignment (¶[0023] and [0043]), the reference is silent with respect to a third orifice with the intended use of cooling.
The reference of Courtney discloses that it is known in the art to provide a heating block (86) sample well (32) with a plurality of orifices (bores)(¶[0057) to allow additional optical interfacing with the sample container.
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide the wells of the reference of Oommen et al. with additional orifices for the known and expected result of allowing additional optical interfacing with the sample container positioned within the well. While the additional orifice is not specifically disclosed as a cooling orifice, the presence of the additional orifice as discussed above would be structurally capable of being used as a cooling orifice.
With respect to claim 14, the optical block has not been positively recited as an element of the claimed device. As result, the device of the modified primary reference would be structurally capable of being used with an optical block with orifices of the claimed diameters.
With respect to claim 15, the reference of Oommen et al. discloses the use of orifices in the heating block with diameters between 0.5 mm and 3.0 mm. (¶[0030]-[0032]).
With respect to claim 16, the reference of Oommen et al. disclose that the heating block can be made of aluminum (¶[0042]). Use of anodized aluminum would have been desirable to protect the block from corrosion.
With respect to claims 17 and 18, the optical block has not been positively recited as an element of the claimed device. As result, the device of the modified primary reference would be structurally capable of being used with an optical block made with the materials recited in claims 7 and 8.
With respect to claims 19 and 20, in the absence of a showing of unexpected results, the diameter and spacing of the wells would have been well within the purview of one having ordinary skill in the art while considering design factors such as the size of the sample vessels to be used in the system while maintaining optimization of the system.
With respect to claim 21, the reference of Oommen et al. discloses:
A limited well thermal cycling device (Figs. 1-9) for preparation of a biological sample for amplification and detection of an analyte, the limited well thermal cycling device comprising:
a heating block (100) configured for preparation of the biological sample and amplification of the analyte, the heating block comprising:
a sample well (101) having a bottom (Fig. 2B and 8B) configured for receiving and preparing the biological sample for amplification and detection, the sample well extending from a top of a heating block base;
a reaction well (101) having a bottom (Fig. 2B and 8B) configured for receiving and amplifying an analyte of the prepared biological sample for detection, the reaction well extending from the top of the heating block base, wherein
the reaction well has an excitation orifice (102) and an emission orifice (103), where the excitation orifice and emission orifice are in 90 degree alignment; and
heating block alignment holes (202), the heating block alignment holes on the top of the heating block base, wherein the heating block alignment holes would be structurally capable of being used for removable attachment of an optical block to the heating block base; the optical block having a means for measuring the real time fluorescence of the analyte of the sample; and
a heating element (404) (¶[0044]) in heating communication with the heating block to provide heat transfer to the sample well and reaction well.
Note: As discussed in the rejection of claim 21 under 35 USC 112(b), the optical block is not considered to be a positively recited structure of the claimed device of claim 21.
Claim 21 first differs by reciting that the sample and reaction wells have flat bottoms.
While the reference of Oommen et al. specifically discloses wells with tapered bottoms (Figs. 2B and 8B), the reference also discloses that the wells (101) may be of any shape and diameter compatible with sample retention (¶[0042]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to determine the optimal well shape based merely on the specifics of the sample holder intended to be used within the device while maintaining the detection and temperature control of the sample within the thermal cycling device.
Additionally, while the reference of Oommen et al. discloses that the excitation and emission orifices are provided in 90 degree alignment (¶[0023] and [0043]), the reference is silent with respect to a third orifice with the intended use of cooling.
The reference of Courtney discloses that it is known in the art to provide a heating block (86) sample well (32) with a plurality of orifices (bores)(¶[0057) to allow additional optical interfacing with the sample container.
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide the wells of the reference of Oommen et al. with additional orifices for the known and expected result of allowing additional optical interfacing with the sample container positioned within the well. While the additional orifice is not specifically disclosed as a cooling orifice, the presence of the additional orifice as discussed above would be structurally capable of being used as a cooling orifice.
With respect to claim 22, the reference of Oommen et al. discloses:
A limited well thermal cycling device (Figs. 1-9) for preparation of a biological sample for amplification and detection of an analyte, the limited well thermal cycling device comprising:
a heating block (100) configured for preparation of the biological sample and amplification of the analyte, the heating block comprising:
a sample well (101) having a tapered bottom (Fig. 2B and 8B) configured for receiving and preparing the biological sample for amplification and detection, the sample well extending from a top of a heating block base;
a reaction well (101) having a tapered bottom (Fig. 2B and 8B) configured for receiving and amplifying an analyte of the prepared biological sample for detection, the reaction well extending from the top of the heating block base, wherein
the reaction well has an excitation orifice (102) and an emission orifice (103), where the excitation orifice and emission orifice are in 90 degree alignment; and
heating block alignment holes (202), the heating block alignment holes on the top of the heating block base, wherein the heating block alignment holes would be structurally capable of being used for removable attachment of an optical block to the heating block base; the optical block configured for detecting the analyte of the amplified and prepared biological sample, wherein the optical block is in removable attachment with the heating block, the optical block comprising
an inner excitation orifice and an outer excitation orifice, the inner excitation orifice having a smaller diameter than the outer excitation orifice where the inner and outer excitation orifice are in continuing alignment through a central portion of the optical block, wherein a center of the inner and outer excitation orifice is in linear alignment with a center of the reaction well excitation orifice; an LED board having an LED, the LED board in removable attachment with the optical block where the LED is received by the outer excitation orifice; a photodiode board having a photodiode, the photodiode board in removable attachment with the optical block where the photodiode is received by the outer emission orifice; an excitation filter, the excitation filter received by a ledge of the outer excitation orifice, the ledge formed by the continuing alignment between the inner and outer excitation orifice; an emission filter, the emission filter received by a ledge of the outer emission orifice, the ledge formed by the continuing alignment between the inner and outer emission orifice; and
a heating element (404) (¶[0044]) in heating communication with the heating block to provide heat transfer to the sample well and reaction well.
Note: As discussed in the rejection of claim 1 under 35 USC 112(b), the optical block is not considered to be a positively recited structure of the claimed device of claim 1.
Claim 22 differs for the following reason: While the reference of Oommen et al. discloses that the excitation and emission orifices are provided in 90 degree alignment (¶[0023] and [0043]), the reference is silent with respect to a third orifice with the intended use of cooling.
The reference of Courtney discloses that it is known in the art to provide a heating block (86) sample well (32) with a plurality of orifices (bores)(¶[0057) to allow additional optical interfacing with the sample container.
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide the wells of the reference of Oommen et al. with additional orifices for the known and expected result of allowing additional optical interfacing with the sample container positioned within the well. While the additional orifice is not specifically disclosed as a cooling orifice, the presence of the additional orifice as discussed above would be structurally capable of being used as a cooling orifice.
Claims 2, 3, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Oommen et al. (US 2017/0115222) in view of Courtney (US 2015/0233828) taken further in view of Hong (CN 103881902 and corresponding machine translation).
The combination of the references of Oommen et al. and Courtney has been discussed above with respect to claim 1.
With respect to claims 2, 3, 12 and 13, the reference of Oommen et al. is silent with respect to the material of the reaction vessel (PCR tube) (¶[0029] and [0042]) used within the device.
The reference of Hong discloses that PCR reaction tubes can be made from any number of materials, including glass and plastic (¶[0093] of the translation).
In view of this disclosure and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to employ any of the well know types of PCR tubes within the device of the modified primary reference for the known and expected result of employing an art recognized device for its intend use of holding a sample during thermal cycling.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The references of Bickmore, Jr. et al. (US 7,315,376) and Baumgartner et al. (US 2016/0265040) are cited as prior art which pertains to the optical interrogation of sample wells.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (571)272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB