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 .
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because:
The numbering of the sheets of drawings bearing FIG(s). 1 - 8 is not in compliance with all aspects of 37 CFR 1.84(t).
(t) Numbering of sheets of drawings. The sheets of drawings should be numbered in consecutive Arabic numerals, starting with 1, within the sight as defined in paragraph (g) of this section. These numbers, if present, must be placed in the middle of the top of the sheet, but not in the margin. The numbers can be placed on the right-hand side if the drawing extends too close to the middle of the top edge of the usable surface. The drawing sheet numbering must be clear and larger than the numbers used as reference characters to avoid confusion. The number of each sheet should be shown by two Arabic numerals placed on either side of an oblique line, with the first being the sheet number and the second being the total number of sheets of drawings, with no other marking. (Emphasis added)
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).
Attention is directed to MPEP 2173.04 [R-10.2019]. As stated therein:
Breadth of a claim is not to be equated with indefiniteness. In re Miller, 441 F.2d 689, 169 USPQ 597 (CCPA 1971); In re Gardner, 427 F.2d 786, 788, 166 USPQ 138, 140 (CCPA 1970) ("Breadth is not indefiniteness."). 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)
Claim Rejections - 35 USC § 112, Second Paragraph / (b)
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-01.2024]:
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 [R-01-2024], 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).
Holding and Rationale
Claims 1, 2, 4-6, 8-13, 18-21, 25-26, 28, 31, and 32 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 1 is indefinite with respect to what constitutes the metes and bounds of “a probe” , a “structural unit of the polymer”, and “a linker group”. Claim 1 is also indefinite with regard to what constitutes the metes and bounds of the “chip”. While it is understood that the “chip” is “amino-modified”, it is less than clear as to just what are the “structural units” of the “chip” that were modified. Claims 2, 4-6, 8-11, and 31, which depend from claim 1, fail to overcome the above-identified issues and are similarly rejected.
Claim 8 is indefinite with respect to what constitutes the metes and bounds of “a linker compound”.
Claim 11 is indefinite with respect to what constitutes the metes and bounds of “DBCO”.
Claim 12 is indefinite with respect to what constitutes the metes and bounds of “a substrate” and the “structural unit of the polymer”.
Claims 20 and 21 are indefinite with respect to what constitutes the metes and bounds of “a probe”.
Response to traversal
Applicant’s representative, at pages 8-13 of the response of 11 November 2025, hereinafter the response, traverses the rejection of claims under 35 USC 112(b). On numerous occasions said representative directs attention to where, in the specification, the term has been used or is defined. These arguments have been considered and have not been found persuasive. 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). (Emphasis added)
In view of the above analysis and in the absence of convincing evidence to the contrary, the rejections are maintained.
Claim Rejections - 35 USC § 112
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)
Acknowledgement is made of the fact that claims 12, 13, 18-21, 25, 26, 28, and 32 are to a method and not to a product. However, it is well settled that in order to satisfy the written description for a method, one must also disclose the molecules required to perform the method. In support of this position attention is directed to University of Rochester v. G.D. Searle & Co. 68 USPQ2D 1424 (W.D.N.Y. 2003) at 1433 (affirmed; University of Rochester v. G.D. Searle & Co. 69 USPQ2d 1886 (Fed. Cir. 2004)):
Plaintiff also argues that the requirements for written descriptions of claims to chemical compounds are irrelevant to this case because the '850 patent does not claim a compound, but a method of treatment by targeting PGHS-2 activity over PGHS-1 activity. Virtually any compound claim could be transformed into a method claim, however, simply by means of wording the claim in terms of a method of using the compound. With respect to the issue before the Court, then, this is little more than a semantic distinction without a difference. The claimed method depends upon finding a compound that selectively inhibits PGHS-2 activity. Without such a compound, it is impossible to practice the claimed method of treatment. It means little to “invent” a method if one does not have possession of a substance that is essential to practicing that method. Without that substance, the claimed invention is more theoretical than real; it is, as defendants argue, akin to “inventing” a cure for cancer by utilizing a substance that attacks and destroys cancer cells while leaving healthy cells alone. Without possession of such a substance, such a “cure” is illusory, and there is no meaningful possession of the method.
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What the inventors did not do, however, is succeed in taking the last, critical step of actually isolating such a compound, or at least of developing a process through which one skilled in the art would be directly led to such a compound. Absent that step, their discoveries, valuable though they might have been, did not blossom into a full-fledged, complete invention. Scientific discoveries, and theories based on those discoveries, frequently lay the groundwork for later inventions, but that does not make the discoverer the inventor as well.
Attention is also directed to the decision in Ariad Pharmaceuticals Inc. v. Eli Lilly & Co.
(Fed. Cir. 2010) 94 USPQ2d 1161, 1175, which teaches:
In accordance with Rochester, the ?516 patent must adequately describe the claimed methods for reducing NF-?B activity, including adequate description of the molecules that Ariad admits are necessary to perform the methods. (Emphasis added)
Holding and Rationale
Claims 1, 2, 4-6, 8-12, 20, 21, 25, 26, and 31 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. For convenience claims 1, 12, and 20 are reproduced below.
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Applicant, at page 10, second paragraph, of the disclosure, asserts:
In one of the specific examples, the chip further contains a probe attached onto the polymer. The probe binds to a target molecule and thus captures the target molecule. For different purposes, different probes may be selected. For example, oligonucleotide fragments, polypeptide sequences, probes containing oligonucleotide fragments, or probes containing polypeptide sequences can be selected. Meanwhile, the probes can selectively label fluorescent detection molecules, antigens, biotin, streptavidin, or other detection molecules.
In one of the specific examples, the probe may be a nucleic acid strand and/or a polypeptide. (Emphasis added)
A review of the disclosure does identify a Sequence Listing. Said Sequence Listing has been found to comprise 4 DNA sequence, each of which is identified as being an “Artificial Sequence”.
The disclosure has not been found to disclose the nucleotide sequence for any DNA or RNA target in any organism much less the nucleotide sequence for any probe. Likewise, the disclosure has not been found to disclose the nucleotide sequence for any protein binding aptamer, much less provide the amino acid sequence for any epitope on any protein, much less any polypeptide. Such nondisclosure of such essential material1 has not been found to reasonably suggest that applicant was in possession of the claimed inventions, and thusly, has not satisfied the written description requirements of of 35 USC 112(a). Given such, and in the absence of convincing evidence to the contrary, claims 1, 2, 4-6, 8-12, 20, 21, 25, 26, and 31 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.
Claim Rejections - 35 USC § 103
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 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(s) 1, 2, 4-6, 8-13, 18-21, 25, 26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0009500 A1 (Benters et al.) in view of US 2006/0057631 A1 (Zou et al.), US 2005/0233438 A1 (Dertinger et al.), US 2011/0256552 A1 (Deleris et al.), and US 2020/0087147 A1 (Schnieders et al.).
Benters et a., in their abstract, teach:
Items described herein possess an activated surface for immobilisation of bioorganic macromolecules, i.e.:
a substrate with a surface
a dendrimeric scaffold attached to the substrate surface and
a number of primary residues bound to the dendrimeric scaffold for immobilisation of bioorganic macromolecules.
These items can be manufactured by using a procedure with the following steps:
provision of a substrate with a surface
linkage of the substrate surface with a dendrimeric scaffold and
supply of the dendrimeric scaffold with a number of primary residues for immobilisation of bioorganic macromolecules.
Benters et al., in paragraph [0061], teach:
[0061] An advantageous approach of the invented procedure is to modify large planar substrates with dendrimer layers using the above described steps. Those substrates correspond to a multiples of a chip surface desired.
Benters et al., in paragraph [0062], teach:
[0062] A typical approach is the use of 100.times.100 cm glass slides, but also slides of other materials or even larger measurements. These slides are cleaved into formats of the desired chips using well-known physical, mechanical or chemical procedures. The glass slide (or any other substrate) can then be divided into the format of the chips. These steps are usually followed by a chemical modification as mentioned before (and below), e.g. cleaning, silylating and activating steps, for example using baths. The application of the dendrimers is done following the sandwich-technique, as described earlier. The final activation of the dendrimers by using homo- or heterobiofunctional linkers is preferably performed using the sandwich or bath-treatment. (Emphasis added)
Benters et al., in paragraph [0080], teach:
[0080] The invention also includes items that are molecules (macro or other) linked to a dendrimeric scaffold. This (macro-)molecule can be a member of the following group: antibodies, especially IgG, IgM, IgA, enzymes; receptors; membrane proteins, glycoproteins; carbohydrates; nucleic acids; for example DNA, RNA, peptide nucleic acids (PNA), pyranosyl-ribonucleic acid (pRNA).
Benters et al., in paragraph [0102], teach:
[0102] Dendrimer-based, isothiocyanate- and epoxy-functionalised surfaces that are loaded with for example amino-functionalised oligonucleotides, can be of high interest as sensor surfaces in DNA-chip-technology (Niemeyer, C. M.; Blohm, D. Angew. Chem. 111/19 3039-3043 (1999)). See also FIG. 2 and the corresponding explanations. (Emphasis added)
The aspect of the surfaces have been “functionalized” with “epoxy” is deemed to fairly suggest the use of epoxy as linker, as well as multiple layers of same, which would enhance the ability to bind more of the probe to the surface of the chip.
Benters et al., in paragraph [0116], teach:
[0116] Metal and semiconductor surfaces were activated using well-known procedures, for example by silylation with amino-, epoxy-, carboxy or thiosilanes (Chrisey, L.; O'Ferrall, C. E.; Spargo, B. J.; Dulcey, C. S.; Calvert, J. M. Nucleic Acids Research 24/15 3040-3047 (1996)) and (Bhatia, S. K. et al. Anal. Biochem. 178, 408-413 (1989)) or by hydrosilylation with .omega.-undecencarboacid (Sieval, A. B. et al.; Langmuir 14(7)1759-1768 (1998).
Zou et al., in paragraph [0003], teach:
[0003] Most of present functionalized supports are produced by directly immobilizing functional reagent (e.g. probe-ligand) onto the surface of a support. For example, glass derivatives (such as amino-group glass slide, aldehyde-group glass slide, epoxy-group glass slide, polyamino acid-coated glass slide, etc.) are the main substrates used nowadays for analysis-chips. The immobilized functional reagent, produced by immobilizing the functional reagent onto the substrate, is one of the key factors deciding the test sensitivity and specificity of the analysis-chip. The available immobilization measures are mainly covalent bond immobilization, physicochemical adsorption, embedding, and cross-linking. The reaction kinetic condition for functional reagents is to be optimized and detailed, which is manifested as improved sensitivity or/and specificity; or/and to shortened reaction time. (Emphasis added)
Zou et al., in paragraph [0022], teach:
[0022] In one nano-structured support of this invention: 1). said surface group includes one or more of following surface groupes: amino-, aldehyde-, epoxy-, amino diazane, diethylaminoethyl, diethyl-(2-hydroxypropyl) aminoethyl, carboxymethyl, sulfopropyl, mercaptoethylpyridine, siloxanyl, thioalcohol- and alkyl-; and 2). said organic compound includes one or more groups of following substances: (1). surfactant including polyvinylpyrrolidone or/and Tween; (2). polyelectrolyte including polyamino acid; (3). oleophilic compound including polysiloxane; (4). ion exchange polymer including dextran derivative, agarose derivative, cellulose derivative, or/and polyacrylamide; and (5). affinity materials including heparin natrium, antigen or/and antibody. (Emphasis added)
Zou et al., at paragraph [0025], teach:
[0025] One nano-structured support of this invention, said conventional solid phase support presents a sizes over 1000 nm and is made of one or more groups of following materials or their derivatives: glass, silica, silica gel, ceramics, metallic oxide, metal, polymer material and their complexes, wherein said derivative includes those derived surficially with surface groups or/and coated organic compounds. (Emphasis added)
While Zou et al., teach of immobilizing functional reagents to the surface of a support via a variety of functional groups, including amino, they have not been found to teach that the amino group is either a primary amino or a secondary amino group.
Dertiger et al., in paragraph [0040], teach:
[0040] To complete the preparation of a biochip, capture molecules such as oligonucleotides or DNA molecules may then be bound or coupled to the support material via the linker molecules according to the standard methods of the prior art, for example by treating the porous substrate material, when epoxysilanes are used as linker molecules, by subsequent reaction of the terminal epoxide groups with terminal primary amino groups or thiol groups of oligonucleotides or DNA molecules which, in corresponding analysis methods, function as immobilized or fixed capture molecules for the target molecules present in the analyte to be studied.
Neither Benters et al., Zou et al., nor Dertinger et al., have been found to teach how many units of the polymer can be present.
Deleriset al., in paragraph [044], teach:
As an example and nonexhaustively, this embodiment corresponds to the case of a substrate covered with a thin layer of a siloxane polymer of the polyethylene/polyethylene glycol type or of polylysine (D or L) enabling the fusogenic compound to be fixed. "Polymer" means a repetition of a certain number of monomer units advantageously between 2 and 30. (Emphasis added)
Neither Benters et al., nor Zou et al., nor Deleriset al., have been found to teach using the group “-DBCO” to immobilize probe(s).
Schnieders et al., in paragraph [0174], teach:
[0174] In-situ immobilisation of the DBCO-derivatised Spiegelmer SPM2-DBCO as test probe was used to show that azide-terminated CNMs directly prepared on the surface of the SPR-sensor chips had no distinct difference compared to CNMs functionalised on their initial substrate and then transferred to the SPR-sensor chip (as shown in Example 3). Both chip preparations showed comparable maximal immobilisation levels of the SPM2-DBCO in the range of 1,500±300 RU (response units) when Spiegelmer immobilisation was driven to the maximum (FIG. 12). (Emphasis added)
In view of the above presentation, it would have been obvious to one of ordinary skill in the art to have produced the claimed amino-modified chip and to have used same in the detection of any of a wide variety of biomolecules. In view of the well-developed state of the art and the number of biomolecules of interest, said ordinary artisan would have been amply motivated and would have had a most reasonable expectation of success.
In view of the above analysis and in the absence of convincing evidence to the contrary, claims 1, 2, 4-6, 8-13, 18-21, 25, 26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0009500 A1 (Benters et al.) in view of US 2006/0057631 A1 (Zou et al.), US 2005/0233438 A1 (Dertinger et al.), US 2011/0256552 A1 (Deleris et al.), and US 2020/0087147 A1 (Schnieders et al.).
Claim(s) 31 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0009500 A1 (Benters et al.) in view of US 2006/0057631 A1 (Zou et al.), US 2005/0233438 A1 (Dertinger et al.), US 2011/0256552 A1 (Deleris et al.), and US 2020/0087147 A1 (Schnieders et al.) as applied to claims 1, 2, 4-6, 8-13, 18-21, 25, 26, and 28 above, and further in view of US 2006/0153815 A1 (Seyda et al.).
See above for the basis of the rejection as it pertains to the disclosures of Benters et al., Zou et al., Dertinger et al., Deleris et al., and Schnieders et al.
Neither Benters et al., Zou et al., Dertinger et al., Deleris et al., nor Schnieders et al., have been found to teach having “1 to 5 identical or different amino groups”.
Seyda et al., in paragraph [0026], teach:
[0026] The polymer may also consist of identical or different repeating units of the following general formula (II): ##STR2## wherein R.sup.1 represents a hydrogen atom, a straight-chain or branched alkyl group containing 1 to 6 carbon atoms or a C3-6 cycloalkyl group, R.sup.2 and R.sup.3 each independently represent a alkylene group containing 1 to 6 carbon atoms or R.sup.2 and R.sup.3 may be combined to form a ring, X represents a hydrogen atom, an amino group, a hydroxyl group, a halogen atom, a carboxyl group or a --COOR.sup.4 group wherein R.sup.4 represents a C1-6 straight-chain or branched alkyl, C3-6 cycloalkyl, phenyl, substituted phenyl, benzyl or substituted benzyl group, and Y represents an amino group, a hydroxyl group, a halogen atom, a carboxyl group or a --COOR.sup.4 group wherein R.sup.4 represents a C1-6 straight-chain or branched alkyl, C3-6 cycloalkyl, phenyl, substituted phenyl, benzyl or substituted benzyl group. (Emphasis added)
As evidenced above, it would have been obvious to one of ordinary skill in the art to have modified the methods of Benters et al., Zou et al., Dertinger et al., Deleris et al., and Schnieders et al., whereby one designed the “repeating units”, applicant’s “structural unit”, such that it comprised identical, or different, amino groups.
One of ordinary skill in the art would have been motivated to have incorporated amino groups to the structural unit as it allows for the coupling of a wide variety of molecules/compounds, therein imparting greater functionality of the polymer.
In view of the above analysis and in the absence of convincing evidence to the contrary, claims 31 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0009500 A1 (Benters et al.) in view of US 2006/0057631 A1 (Zou et al.), US 2005/0233438 A1 (Dertinger et al.), US 2011/0256552 A1 (Deleris et al.), and US 2020/0087147 A1 (Schnieders et al.) as applied to claims 1, 2, 4-6, 8-13, 18-21, 25, 26, and 28 above, and further in view of US 2006/0153815 A1 (Seyda et al.).
Conclusion
Objections and/or rejections which appeared in the prior Office action and which have not been repeated hereinabove have been withdrawn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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..
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/Bradley L. Sisson/Primary Examiner, Art Unit 1682
1 Attention is directed to 37 CFR 1.57(d), which sates in part:
(d) "Essential material" may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. "Essential material" is material that is necessary to:
(1) Provide a written description of the claimed 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 set forth the best mode contemplated by the inventor of carrying out the invention as required by 35 U.S.C. 112(a);
(2) Describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b); or
(3) Describe the structure, material, or acts that correspond to a claimed means or step for performing a specified function as required by 35 U.S.C. 112(f). (Emphasis added)
(e) Other material ("Nonessential material") may be incorporated by reference to U.S. patents, U.S. patent application publications, foreign patents, foreign published applications, prior and concurrently filed commonly owned U.S. applications, or non-patent publications. An incorporation by reference by hyperlink or other form of browser executable code is not permitted.