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 without traverse of Group II, 13-17, drawn to "a configuration of the nucleic acid detection chip", classified in C07H 21/00 and Claim 18, drawn to "apparatuses of the nucleic acid detection chip", in the reply filed on 26 September 2025 is acknowledged.
Claims 1-12 and 19-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 September 2025.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because:
Figure(s) 1A – 7B is/are not properly labeled. Note the required use of FIG., not “Fig.” See 37 CFR 1.84(u)(1).
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
INFORMATION ON HOW TO EFFECT DRAWING CHANGES
Replacement Drawing Sheets
Drawing changes must be made by presenting replacement sheets which incorporate the desired changes and which comply with 37 CFR 1.84. An explanation of the changes made must be presented either in the drawing amendments section, or remarks, section of the amendment paper. 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). A replacement sheet must 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 the amended drawing(s) must not be labeled as “amended.” If the changes to the drawing figure(s) are not accepted by the examiner, applicant will be notified of any required corrective action in the next Office action. No further drawing submission will be required, unless applicant is notified.
Identifying indicia, if provided, should include the title of the invention, inventor’s name, and application number, or docket number (if any) if an application number has not been assigned to the application. If this information is provided, it must be placed on the front of each sheet and within the top margin.
Annotated Drawing Sheets
A marked-up copy of any amended drawing figure, including annotations indicating the changes made, are required by the examiner. The annotated drawing sheet(s) must be clearly labeled as “Annotated Sheet” and must be presented in the amendment or remarks section that explains the change(s) to the drawings.
Timing of Corrections
Applicant is required to submit acceptable corrected drawings within the time period set in the Office action. See 37 CFR 1.85(a). Failure to take corrective action within the set period will result in ABANDONMENT of the application.
If corrected drawings are required in a Notice of Allowability (PTOL-37), the new drawings MUST be filed within the THREE MONTH shortened statutory period set for reply in the “Notice of Allowability.” Extensions of time may NOT be obtained under the provisions of 37 CFR 1.136 for filing the corrected drawings after the mailing of a Notice of Allowability.
Claim Interpretation
Attention is directed to MPEP 904.01 [R-08.2012].
The breadth of the claims in the application should always be carefully noted; that is, the examiner should be fully aware of what the claims do not call for, as well as what they do require. During patent examination, the claims are given the broadest reasonable interpretation consistent with the specification. See In re Morris, 127 F.3d 1048, 44 USPQ2d 1023 (Fed. Cir. 1997). See MPEP § 2111 - § 2116.01 for case law pertinent to claim analysis.
It is noted with particularity that narrowing limitations found in the specification cannot be inferred in the claims where the elements not set forth in the claims are linchpin of patentability. In re Philips Industries v. State Stove & Mfg. Co, Inc., 186 USPQ 458 (CA6 1975). While the claims are to be interpreted in light of the specification, it does not follow that limitations from the specification may be read into the claims. On the contrary, claims must be interpreted as broadly as their terms reasonably allow. See Ex parte Oetiker, 23 USPQ2d 1641 (BPAI, 1992). In added support of this position, attention is directed to MPEP 2111 [R-11.2013], where, citing In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-51 (CCPA 1969), is stated:
The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.
Additionally, attention is directed to MPEP 2111.01 [R-01.2024], wherein is stated:
II. IT IS IMPROPER TO IMPORT CLAIM LIMITATIONS FROM THE SPECIFICATION
“Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.” Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004).
Attention is also directed to MPEP 2111.02 II [R-07.2022]. As stated herein:
II. PREAMBLE STATEMENTS RECITING PURPOSE OR INTENDED USE
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The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "'extraneous' limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation")… (Emphasis added)
Attention is directed to MPEP 2111 [R-10.2019]. As stated therein:
During patent examination, the pending claims must be "given their broadest reasonable interpretation consistent with the specification." The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the "broadest reasonable interpretation" standard:
The Patent and Trademark Office ("PTO") determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction "in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must "conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description." 37 CFR 1.75(d)(1). (Emphasis added).
Claim Rejections - 35 USC § 112, (b) / Second Paragraph
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.
Standard for Definiteness.
Attention is directed to MPEP 2171 [R-11.2013]:
Two separate requirements are set forth in 35 U.S.C. 112(b) and pre-AIA 35 U.S.C. 112, second paragraph, namely that:
(A) the claims must set forth the subject matter that the inventor or a joint inventor regards as the invention; and
(B) the claims must particularly point out and distinctly define the metes and bounds of the subject matter to be protected by the patent grant.
The first requirement is a subjective one because it is dependent on what the inventor or a joint inventor for a patent regards as his or her invention. Note that although pre-AIA 35 U.S.C. 112, second paragraph, uses the phrase "which applicant regards as his invention," pre-AIA 37 CFR 1.41(a) provides that a patent is applied for in the name or names of the actual inventor or inventors.
The second requirement is an objective one because it is not dependent on the views of the inventor or any particular individual, but is evaluated in the context of whether the claim is definite — i.e., whether the scope of the claim is clear to a hypothetical person possessing the ordinary level of skill in the pertinent art.
Attention is directed to MPEP 2173.02 I [R-07.2022]:
During prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude. See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc). As the Federal Circuit stated in Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008):
“We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiners demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.”
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During examination, after applying the broadest reasonable interpretation to the claim, if the metes and bounds of the claimed invention are not clear, the claim is indefinite and should be rejected. Packard, 751 F.3d at 1310 (“[W]hen the USPTO has initially issued a well-grounded rejection that identifies ways in which language in a claim is ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention, and thereafter the applicant fails to provide a satisfactory response, the USPTO can properly reject the claim as failing to meet the statutory requirements of § 112(b).”); Zletz, 893 F.2d at 322, 13 USPQ2d at 1322.
Attention is also directed to MPEP 2173.02 III B, which states in part:
To comply with 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, applicants are required to make the terms that are used to define the invention clear and precise, so that the metes and bounds of the subject matter that will be protected by the patent grant can be ascertained. See MPEP § 2173.05(a), subsection I. It is important that a person of ordinary skill in the art be able to interpret the metes and bounds of the claims so as to understand how to avoid infringement of the patent that ultimately issues from the application being examined. See MPEP § 2173.02, subsection II (citing Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470 (Fed. Cir. 1993)); see also Halliburton Energy Servs., 514 F.3d at 1249, 85 USPQ2d at 1658 (“Otherwise, competitors cannot avoid infringement, defeating the public notice function of patent claims.”). Examiners should bear in mind that “[a]n essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.” Zletz, 893 F.2d at 322, 13 USPQ2d at 1322 [Fed. Cir. 1989]. (Emphasis added)
Attention is also directed to MPEP 2173.04 [R-10.2019], which states in part:
A broad claim is not indefinite merely because it encompasses a wide scope of subject matter provided the scope is clearly defined. But a claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear. For example, a genus claim that covers multiple species is broad, but is not indefinite because of its breadth, which is otherwise clear. But a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim). (Emphasis added)
Holding and Rationale
Claims 13-18 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.
Claim 13 recites the limitation “the nucleic acid detection chip” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 is indefinite with regard to just which material(s) “the chip”, “the first body”, “the plate”, “the second body”, “the substrate” and “the light conversion materials” are comprised of as well as the general size, or range of sizes, of “the chip”.
Claim 13 recites the limitation "the first body”, “the second body”, and “the plate side" in lines 3 and 4. There is insufficient antecedent basis for these limitations in the claim.
Claim 13 recites the limitation "the first injection hole” and “the first guide hole" in lines 5 and 6. There is insufficient antecedent basis for these limitations in the claim.
Claim 13 is confusing as to what difference, if any, there is between “the groove” and “the light transmitting groove”.
Claim 13 is indefinite with respect to what constitutes the metes and bounds of “the light source” and what electrical connections, if any, are provided so to power “the light source”.
Claim 13 is confusing as to where and how the “light-transmitting groove” obtains the light that it transmits.
Claim 13 is confusing as to how “the plate causes the light-transmitting groove to be displaced above the hole”. (Emphasis added)
Claim 13 is indefinite with respect to how “the plate causes the light-transmitting groove to be above the hole and attracts the detection sample”.
Claim 13 recites the limitation "the test sample" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the first magnetic element" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the first light" in line 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 is indefinite with respect to just what type(s) and size(s)/volume(s) of “sample”, be it “a detection sample” or “the test sample” are encompassed by the claim.
Claim 13 is indefinite with respect to what constitutes the metes and bounds of “light conversion materials” (line 14).
Claim 13 is indefinite with respect to what materials, of what shapes and volumes (e.g., depth, width and length), of the “light-transmitting groove” are encompassed.
Claim 13 is indefinite with respect to what constitutes the metes and bounds of the “light conversion materials”.
Claim 13 is indefinite with respect to the size, shape and orientation of “a hole” (line 3). It is also unclear if the “hole” being referenced in line 3 is either the “first injection hole” and/or “the first guide hole” or whether it is something different.
Claim 13 recites the limitation "the photoelectric element" in lines 14 and 15. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 is indefinite with respect to the difference(s) between “the first light” and “the second light”.
Claim 13 is confusing where in line 13, bridging to line 14, is stated “and he light conversion materials”. (Emphasis added) Perhaps applicant had intended to use the word >>the<<, not “he”.
Claim 13 is confusing where in line 8 is stated “wherein the groove contains a detection sample, which has the test sample”, yet in dependent claim 14, line 1, it is specified that “the test sample is injected into the groove via the first injection hole and first guide hole”. It is unclear if the “nucleic acid detection chip” already comprises a sample and another is being introduced via the injection “into the groove via the first injection hole and first guide hole” without there being any step(s) of removing the first sample prior to introduction of a second sample, or whether claim 14 is to be clarifying how the sample came to be in the groove.
Claims 14-17, which depend from claim 13, fail to overcome the above-identified issues and are similarly rejected.
Claim 14 recites the limitation "the protein kinase" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 is indefinite with respect to what form(s) of “a heating element” is/are encompassed by the claim, and to what degree can the substrate be heated and cooled.
Claim 14 is indefinite with respect to what size(s) and shape(s) of the nanoparticles are encompassed.
Claim 15 is indefinite with respect to whether the “cooling line” is open or closed. Said claim 15 is also indefinite with respect to what type(s) and volume(s) of “coolant” is/are contained in the “cooling line”.
Claim 16 is confusing as to whether the recited range of wavelengths (“200nm to 700nm”), is the range in wavelengths of light before its being acted upon by the “light conversion materials” or after having been acted upon by said “light conversion materials”.
The term “bigger” in claim 17 is a relative term which renders the claim indefinite. The term “bigger” 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.
Claim 18 recites the limitation "the nucleic acid" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the first body" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the first injection hole" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the first guide hole” and “the light-transmitting groove” in lines 6-7. There is insufficient antecedent basis for these limitations in the claim.
Claim 18 recites the limitation "the test sample" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 is indefinite with respect to what shape(s), length(s), thickness(es) and/or diameter(s) are encompassed in each of “a carry base”, “a sliding chip element”, “a substrate”, “the first body”, the “plate”, “groove” and “hole”.
Claim 18 recites the limitation "the detection sample" in line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the first magnetic element" in lines17-18. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the light conversion material" in line 20. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 is indefinite with respect to the size, shape, thickness and composition of the “carry base”, the “plate slide” and the “substrate” that “the plate slide is on”.
Claim 18 is indefinite with respect to what constitutes the metes and bounds of “a moving element” and “a display element” and the physical arrangement of same.
Claim 18 is indefinite with respect to just which type(s) of electrodes is/are present and which are “electrically connected” or not. Said claim 18 is also indefinite with respect to what type(s) of “a detection sample” is/are present and what form(s) of “the test sample” can be introduced.
Claim 18 is indefinite with respect to the size and orientation of the first and any later “injection hole”, the volume of fluid that can be introduced, retained and any means for removal/replacement of such fluids.
Claim 18 is indefinite with respect to what changes in wavelength are needed in order to constitute converting “the first light to the second light”.
The term “attracts” in claim 18 at line 17 is a relative term which renders the claim indefinite. The term “attracts” 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.
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 13 has the limitation “and through sliding, the plate causes the light-transmitting groove to be above the groove and attracts the detection sample to the light-transmitting groove by the first magnetic element”. This claim has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim begins with the clause “a configuration of the nucleic acid detection chip”, yet the claim limitations do not start with either “means” or “step”. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. It is noted that claims 14-17 depend from claim 13 and present the same issue. Similar concerns exist with regard to claim 18 for like claim 13, it does not employ the terms means or step in defining the limitations.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claim Rejections - 35 USC § 112, Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Standard for Written Description.
Attention is directed to MPEP 2163.02 Standard for Determining Compliance With the Written Description Requirement [R-07-2022]:
An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. (Emphasis added)
Attention is also set directed to MPEP 2161.01 I [R-07-2022], wherein is stated:
For instance, generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. Ariad, 598 F.3d at 1349-50, 94 USPQ2d at 1171 ("[A]n adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries.") (citing Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002) (holding that generic claim language appearing in ipsis verbis in the original specification did not satisfy the written description requirement because it failed to support the scope of the genus claimed); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (rejecting the argument that "only similar language in the specification or original claims is necessary to satisfy the written description requirement").
As set forth in Fiers v. Revel 25 USPQ2d 1601, 1604-5 (CAFC, January 1993):
We thus determined that, irrespective of the complexity or simplicity of the method of isolation employed, conception of a DNA, like conception of any chemical substance, requires a definition of that substance other than by its functional utility.
Fiers' attempt to distinguish Amgen therefore is incorrect. We also reject Fiers' argument that the existence of a workable method for preparing a DNA establishes conception of that material. (Emphasis added)
Conception of a substance claimed per se without reference to a process requires conception of its structure, name, formula, or definitive chemical or physical properties...
The difficulty that would arise if we were to hold that a conception occurs when one has only an idea of a compound, defining it by its hoped-for function, is that would-be inventors would file patent applications before they had made their inventions and before they could describe them. That is not consistent with the statute or the policy behind the statute, which is to promote disclosure of inventions.
Attention is also directed to MPEP 2163 Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph, “Written Description” Requirement [R-01-2024], at part II ii):
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).") (Emphasis added)
Attention is also directed to the decision of University of California v. Eli Lilly and Co. (CA FC, July 1997) 43 USPQ2d 1398 wherein is stated:
In claims involving chemical materials, generic formulas usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate written description of the claimed genus. In claims to genetic material, however, a generic statement such as “vertebrate insulin cDNA” or “mammalian cDNA,” without more, is not an adequate written description of the genus because it does not distinguish the claimed genus from others, except by function. It does not specifically define any of the genes that fall within its definition. It does not define any structural features commonly possessed by members of the genus that distinguish them from others. One skilled in the art therefore cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus. A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). It is only a definition of a useful result rather than a definition of what it achieves as a result. Many such genes may achieve that result. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 222 USPQ 369, 372-373 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”). Accordingly, naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.
Thus, as we have previously held, a cDNA is not defined or described by the mere name cDNA,” even if accompanied by the name of the protein that it encodes, but requires a kind of specificity usually achieved by means of the recitation of the sequence of nucleotides that make up the cDNA. See Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606.
Holding and Rationale
Claims 13-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 13-17 are drawn to “a configuration of the nucleic acid detection chip” and claim 18 is drawn to “apparatuses of the nucleic acid detection chip”.
As seen in claim 13, the detection chip is to comprise a “sliding chip element”, a “first body”, a “second body”, a “plate slide”, a “substrate”, a “light source”, a “light transmitting groove”, a “coolant”, “a light filter element”, “a light-transmitting element”, and “the test sample”. A review of the disclosure fails to find where applicant has identified any material, or combination of materials, that the claimed “detection chip”, and “carry base” (claim 18) are made of/comprise. Additionally, a review of the disclosure fails to find where applicant has provided an adequate description of the genus of “detection samples” (claim 18, line 14). Likewise, a review of the disclosure fails to find where applicant has provided any example of the means and conditions needed to produce the claimed “detection chip” and “carry base”. Applicant’s nondisclosure of such essential aspects of the claimed invention do not support the position that applicant, as of the effective priority date (05 July 2022), was in possession of the claimed genus of “nucleic acid detection chip[s]” (claims 13-17) and “apparatuses” (claim 18).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2022/0099621 A1 (Chang et al.)
[0019] FIGS. 1 to 7 illustrate a nucleic acid detection kit 100, which includes a kit body 1, a detection chip 2, and an electrophoresis box 3. The detection chip 2 is disposed in the kit body 1. The electrophoresis box 3 is disposed outside of the kit body 1. The detection chip 2 is connected to the electrophoresis box 3. The detection chip 2 is used to perform a PCR amplification reaction. The electrophoresis box 3 is used to perform analysis by an electrophoretic process. The detection chip 2 includes a first cover plate 21, a spacer layer 22, and a second cover plate 23. Two opposite surfaces of the spacer layer 22 are in contact with the first cover plate 21 and the second cover plate 23 respectively. The first cover plate 21, the spacer layer 22, and the second cover plate 23 cooperatively define a channel 5 configured for carrying a testable material in solution (“solution”) to be detected. The solution in the channel 5 is in a form of microbead The microbead “a” may undergo the PCR amplification reaction to obtain a mixed microbead “b”. (Emphasis added)
US 2005/0164375 A1 (Inoue)
[0053] When the nucleic acid detection apparatus 100 starts operating, first, the arm 10 of the dispensing mechanism 4 is moved from the initial position above the chip disposal unit 3 to the chip holder 7. Then, at the chip holder 7, the two syringes 11 of the dispensing mechanism 4 are lowered in the Z-axis direction in the drawing. In this way the tips of the two syringes 11 are respectively press fitted into a top opening on the pipette chip 12 arranged in the chip holder 7, and the pipette chip 12 is automatically installed on the tip of each syringe 11.
US 2020/0118988 A1 (Yueh et al.), at paragraph [0050]:
[0050] In Embodiment 2, the first electronic elements 1212 comprises LED chips capable of emitting different colors. In the present embodiment, the first electronic element 1212 emitting red color (R) comprises: an LED chip 1212a capable of emitting blue color; and a light conversion element 1212b disposed on the LED chip 1212a to convert the blue light emitting from the LED chip 1212a into red light. The light conversion element 1212b may comprise quantum-dot, phosphors, or photoresist. Similarly, the first electronic element 1212 emitting green color (G) comprises: a LED chip 1212a capable of emitting blue color; and a light conversion element 1212b disposed on the LED chip 1212a to convert the blue light emitting from the LED chip 1212a into green light. The first electronic element 1212 emitting blue color (B) comprises: a LED chip 1212a capable of emitting blue color; and a light scattering element 1212c containing scattering particles and disposed on the LED chip 1212a. In addition, a buffer layer 1216 is further disposed between the LED chip 1212a and the light conversion element 1212b. The buffer layer 1216 blocks the light conversion element 1212b from directly contacting the LED chip 1212a because the heat generated by the LED chip 1212a may damage the light conversion element 1212b. The buffer layer 1216 may comprise epoxy or silicone. In addition, a light alternating layer 1218 is further disposed on the light conversion elements 1212b of the first electronic elements 1212 emitting red color (R) and green color (G) to filter out the residual blue color which are not converted by the light conversion elements 1212b. In some embodiments, the light scattering element 1212c can be replaced by a polymer layer without containing scattering particles.
US 5,580,747 (Shultz et al.), at column 24:
Lane 2: Promega Peptide 3 (SEQ ID NO:3) that had been incubated with cAMP-dependent protein kinase for 30 minutes at room temperature (23.degree. C.). (Emphasis added)
US 7,585,662 B2 (Weiblen et al.)
The present invention relates to a receptacle for accommodating an analysis chip, e.g., chip for the molecular analysis, and a device for accommodating such a receptacle.
US 2014/0211204 A1 (Stedtfeld et al.)
[0193] The hand-held fluorescence gene amplification device can include multiple light-emitting diodes (LEDs), optical fibers, photodiodes, a CCD camera (or CCD) and combinations thereof for measuring light signals from nucleic acid amplification assays of biological samples; and microfluidic chips as assay containers. In some embodiments, the nucleic acid amplification device includes one or more light-emitting diodes (LEDs) as illumination sources, each operably coupled to a single photodiode capable multiply detecting light signals from an amplification assay to track the progress of an amplification reaction. The amplification reactions each occur within a reaction well of a molded, carved, or laser-cut thin plastic microfluidic chip, that can have multiple reaction wells and multiple microchannels. The device software is controlled by tablet or smart devices, such as iPod Touch, iPhone and Google Android Tablets, or other wireless interface modules such as a touch screen computational phone, PDA, and a music player with wireless capabilities. The overall system provides an economical, battery powered and hand-held device for detecting light emitted from reporter molecules incorporated into amplified DNA, RNA, microRNA and other nucleic acid molecules. In some embodiments, this detection and analysis occurs faster than bench top PCR machines. Thus, the devices and methods described herein operate in real time. Nucleic acids amplification may be accomplished using one of many isothermal nucleic acid amplification processes (methods), including loop mediated isothermal amplification (LAMP). The real-time hand-held nucleic acid amplification device of the present invention can be used for detecting amplification light signals from microRNAs, DNA of pathogenic and beneficial microorganisms, bacterial cells, fungal spores, in as little as 10 minutes. In some embodiments, nucleic acids were detected from a single cell. In some embodiments, nucleic acids were directly detect from disrupted cell samples. In some embodiments, nucleic acids were directly detected from cell samples that had not been pretreated or lysed prior to sample introduction into the device. In some embodiments, optical energy (e.g., fluorescence of chemiluminescence) can be directly measured in wells by a CCD camera without the use of fiber optics or a photodiode. In further embodiments, wherein the measurements are made with CCD cameras, fluorescence is measured without the use of an emissions filter. (Emphasis added)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradley L. Sisson whose telephone number is (571)272-0751. The examiner can normally be reached Monday to Thursday, from 6:30 AM to 5 PM..
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, Wu-Cheng Shen can be reached at 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bradley L. Sisson/Primary Examiner, Art Unit 1682