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:
Figure(s) 1-16 is/are not properly labeled. Note the required use of FIG., not Fig. nor Figure. See 37 CFR 1.84(u)(1).
The lettering is not of proper size, uniform density, and well-defined in Figure(s) 1A – 3B. 5A – 8D, 9B, 10B-11, and 12D. See 37 CFR 1.84(p)(1) – (5). (“Numbers, letters, and reference characters must measure at least .32 cm (1/8 inch) in height.”)
The lines are not clean, well-defined, and of uniform thickness in Figure(s) 3A, 13A – 13C and 13E. See 37 CFR 1.84(l) and (q).
The scale of drawings in Figures(s) 1A, 1B, 6A, 13A – 13C, and 13E is not of sufficient size. See 37 CFR 1.84(k).
The margins are not of proper size in Figure(s) 1-16. See 37 CFR 1.84(g).
Framing of figures is not permitted (see Figure(s) ***). See 37 CFR 1.84(g).
Each panel needs to be individually labeled, e.g., FIG. ***. See 37 CFR 1.84(u)(1) and (2),
In Figure(s) 8A-8D, 11-12C, and 16 the reference characters, sheet numbers, and view numbers are not all oriented in the same direction so as to avoid having to rotate the sheet. See 37 CFR 1.84(p)(1).
The numbering of the sheets of drawings bearing FIG(s). 1A - 16 is not in compliance with all aspects of 37 CFR 1.84(t).
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.”
***
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 1, 3, 7, 9-13, 31, 32, 41, 45-47, 54, and 59-62 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 “multimodal detection”, “biomolecule”, “multifunctional anchoring agent”, “epoxide compound”, “a polymer material”, and “physically expanding”.
Claims 3, 7, 9-13, 31, 32, 41, 45-47, 54, and 59-62, which depend from claim 1, fail to overcome the above identified issues and are similarly rejected.
The term “plurality” in claim 7 is a relative term which renders the claim indefinite. The term “plurality” 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.
The term “more” in claim 10 is a relative term which renders the claim indefinite. The term “more” 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 13 is indefinite with respect to what constitutes the metes and bounds of “a precursor molecule”.
The term “more” in claim 41 is a relative term which renders the claim indefinite. The term “more” 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 41 is indefinite with respect to what constitutes the metes and bounds of “an identity” and “expanded biomolecule(s)”.
Claims 45-47 and 59-62, which depend from claim 41, fail to overcome the above identified issues and are similarly rejected.
Claim 45 is indefinite with respect to what constitutes the metes and bounds of “capturing spatial data”.
Claim 54 is indefinite with respect to what constitutes the metes and bounds of “detectably labeling the biomolecule”.
The term “more” in claim 60 is a relative term which renders the claim indefinite. The term “more” 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 60 is confusing as to how one is to be “classifying one or more of the detected spatial position, structure and component of the expanded biomolecule(s) into one or more contiguous biomolecule molecule.”
The term “more” in claim 61 is a relative term which renders the claim indefinite. The term “more” 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 61 is indefinite with respect to what constitutes the metes and bounds of “classifying the detected homogeneous biomolecule material into one or more contiguous biomolecules”.
The term “aids” in claim 61 is a relative term which renders the claim indefinite. The term “aids” 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 62, which depends from claim 61, fails to overcome this issue and is similarly rejected.
The term “more” in claim 62 is a relative term which renders the claim indefinite. The term “more” 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 64 is indefinite with respect to what constitutes the metes and bounds of “a cell”. For example, it is unclear if it includes plant cells, e.g., trees or seaweed, and/or bacteria, and/or blood cells from any organism, and it is unclear if it includes chicken eggs as well as wild bird eggs, including Ostridge eggs.
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.
Claims 1, 41, 47, 59 and 62 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, 41, 59, and 62 are reproduced below.
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For purposes of examination, the claimed method has been construed as encompassing the detection of any “disease or condition” that may occur in any life form, be it plant, microbe, insect or animal, including humans. Such sequences have ben construed as encompassing any sequence on any human chromosome, including that of the human Y chromosome which was not completely sequenced until 2023. In support of this position attention is directed to “The complete sequence of a human Y chromosome”, Rhie et al., Nature, vol. 621, 14 September 2023, pp. 344-354.
A review of the disclosure does identify a Sequence Listing. Said Sequence Listing is found to comprise but a single nucleotide sequence, but then it is identified as being both DNA and a “synthetic construct”. A review of the disclosure fails to find where applicant has provided such essential material1 that establishes that applicant, as of the effective priority date 01 April 2022, was in possession of the full genus of such sequences.
In view of the above analysis and in the absence of convincing evidence to the contrary, claims 1, 41, 47, 59 and 62 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.
Admissions as Prior Art.
Attention is directed to MPEP 2129 [R-07.2022], Admissions as Prior Art, which states in part:
A statement by an applicant in the specification or made during prosecution identifying the work of another as "prior art" is an admission which can be relied upon for both anticipation and obviousness determinations, regardless of whether the admitted prior art would otherwise qualify as prior art under the statutory categories of 35 U.S.C. 102. Riverwood Int’l Corp. v. R.A. Jones & Co., 324 F.3d 1346, 1354, 66 USPQ2d 1331, 1337 (Fed. Cir. 2003); Constant v. Advanced Micro-Devices Inc., 848 F.2d 1560, 1570, 7 USPQ2d 1057, 1063 (Fed. Cir. 1988). Where the admitted prior art anticipates the claim but does not qualify as prior art under any of the paragraphs of 35 U.S.C. 102, the claim may be rejected as being anticipated by the admitted prior art without citing to 35 U.S.C. 102.
Attention is also directed to Ex parte Shirley, (BPAI, 2009) Appeal No. 2009002352, which, at pages 21 and 26, states:
The Specification’s omission of the term “prior art” and inclusion of the prior-art disclaimer may initially appear to indicate that Appellants do not consider the single-step soft bake process to constitute prior art. To place these latter, contraindicative factors into the proper context though, we note that patent-application drafters regularly endeavor to avoid the indiscriminate or imprudent use of the descriptive label, “prior art.” See Riverwood Intern. Corp. v. R.A. Jones & Co., Inc., 324 F.3d 1346, 1354 (Fed. Cir. 2003) (citing In re Fout, 675 F.2d 297, 300 (CCPA 1982)) for the proposition that “section 102 is not the only source of … prior art. Valid prior art may be created by the admissions of the parties”); In re Nomiya, 509 F.2d 566, 571 (CCPA 1975) (holding that an Applicant’s labeling of certain figures as “prior art,” ipsissimis verbis, constituted an admission that the pictured subject matter was prior art relative to Applicant’s invention); MPEP § 21294 (instructing that “the examiner must determine whether the subject matter identified as ‘prior art’ is applicant’s own work, or the work of another. In the absence of another credible explanation, examiners should treat such subject matter as the work of another”).
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The Specification’s omission of the term “prior art” and inclusion of the boilerplate prior-art disclaimer do not change our conclusion. In view of the record as a whole, these factors are ineffective in shielding Appellants from having their prior-art admissions treated as such.
Holding and Rationale
Claim(s) 1, 3, 7, 9, 11-13, 31, 32, 41, 45, 47, 54, 59-62 and 64 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0276578 A1 (Vaughan et al.) in view of US 8,647,644 B1 (Torney et al.), US 5,739,180 (Taylor-Smith), US 2003/0210455 A1 (Tseng et al.), and admissions of applicant.
Vaughan et al., at paragraph [0006] teach:
[0008] In one aspect, the disclosure provides a method for preparing an expanded sample for microscopy comprising: (a) incubating a fixed cell sample or a fixed tissue sample comprising a detectably labeled moiety with a linking agent, for a time and under conditions to promote cross-linking by the linking agent of a target in the sample to the detectably labeled moiety, to produce a cross-linked sample; (b) permeating the cross-linked sample with hydrophilic monomers to produce a permeated sample; (c) polymerizing the monomers within the permeated sample to provide a water-swellable composition; (d) incubating the water-swellable composition for a time and under conditions to promote the formation of linkages between the linking agent and the water-swellable composition, to produce an anchored sample; (e) treating the anchored sample with a homogenizing agent for a time and under conditions to promote homogenization of the anchored sample, to produce a processed sample; and (f) dialyzing the processed sample in water, thereby expanding the water-swellable composition in the processed sample to produce an expanded sample. In certain embodiments, the linking agent comprises a polymerizable group (e.g., a vinyl moiety) and a label-reactive group (e.g., an aldehyde, an N-hydroxysuccinimidyl ester, a maleimide, an epoxide, a thiosulfonate, an imidoester, a pentafluorophenyl ester, a haloacetyl, a thiosulfonate, a vinylsulfone, a pyridylsulfide, or a carbodiimide group). (Emphasis added)
Vaughan et al., at paragraph [0077] teach:
[0077] Also provided are reagents and kits thereof for practicing one or more of the above-described methods. Reagents and kits may include one or more of the following: a linking agent; hydrophilic monomers; reagents for polymerizing the hydrophilic monomers to the water-swellable composition; and a homogenizing agent. Additionally, the kit may include clearing reagents, a detection macromolecule (e.g., labeled and or un-labeled antibodies, nucleic acid probes, and oligonucleotides), buffers (e.g. buffer for fixing, washing, clearing, and/or staining samples), mounting medium, embedding molds, and dissection tools). The reagents and kits thereof may vary greatly. (Emphasis added)
Vaughan et al., at paragraph [0048] teach:
[0048] As used herein, a “detectably labeled moiety” refers to labels useful in localizing to a target (e.g., proteins, lipids, steroids, nucleic acids, extracellular matrix, and sub-cellular structures) in a cell or tissue sample and providing a detectable signal. In an embodiment, the target can be diagnostic. In another embodiment, the target can be prognostic. In certain embodiments, the target can be predictive of responsiveness to a therapy. In some embodiments, the target can be candidate agents in a screen (e.g., a screen for agents that will aid in the diagnosis and/or prognosis of disease, in the treatment of a disease). In certain embodiments, the detectably labeled moiety or label provides an optically detectable signal. (Emphasis added)
Torney et al., at column 24, last paragraph, teach:
Thin sections of samples embedded in epoxide were obtained with ultramicrotomy (60-80 nm). The resulting sample was examined with a Philips model CM-30 TEM operated at 300 kV. (Emphasis added)
Taylor-Smith, at column 6, fourth paragraph, teach:
Thus, it is preferable to select a monomer that is known to produce a plastic possessing a greater measure of the desired property than one producing a plastic possessing a lesser measure of the property. Without limitation, acrylate, epoxide and styrerie monomer are suitable for forming the hybrid IOC substrates of the present invention. It is within the capabilities of those skilled in the art to select other monomers suitable for the present purpose. (Emphasis added)
Tseng et al., at paragraph [0032], teach:
A combination of a multifunctional epoxide and a multifunctional acrylate is also very useful to achieve desirable physicomechanical properties.
The above showing is deemed to fairly suggest limitation of claim 11.
Applicant, at page 42, lines 21-24, admits:
It has been demonstrated that polyepoxide enables controlled inter- and intramolecular crosslinking and therefore transforms the treated tissues being resistant to degradation under harsh conditions, such as heating [Park, Y. G. et al., Nat Biotechnol (2018), Vol. 10(1038)]. Emphasis added)
Applicant, at page 46 admits:
Considering the high reactivity of epoxide, it could potentially react with the amine groups on adenine and cytosine if they are properly exposed from DNA (e.g., by
denaturation). [Park, Y. G. et al., Nat Biotechnol (2018), Vol. 10(1038)] This would result in a higher labeling efficiency by using epoxides than LabelX for genome probing.
In view of the above presentation, it would have been quite obvious to one of ordinary skill in the art to have prepared a biospecimen by embedding the sample, which can be fixed and embedded in a polymer such as epoxide (Vaughan et al., and Torney et al.). It would have also been quite obvious to the ordinary artisan to have used the fixed sample in a method of diagnosis (Vaughan et al.).
In view of the well-developed state of the art the and the ability to effectively use alternative forms of an epoxide, 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, 3, 7, 9, 11-13, 31, 32, 41, 45, 47, 54, 59-62 and 64 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0276578 A1 (Vaughan et al.) in view of US 8,647,644 B1 (Torney et al.), US 5,739,180 (Taylor-Smith), US 2003/0210455 A1 (Tseng et al.), and admissions of applicant.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0276578 A1 (Vaughan et al.) in view of US 8,647,644 B1 (Torney et al.), US 5,739,180 (Taylor-Smith), US 2003/0210455 A1 (Tseng et al.), and admissions of applicant as applied to claims 1, 3, 7, 9, 11-13, 31, 32, 41, 45, 47, 54, 59-62 and 64 above, and further in view of US 2012/0132870 A1 (Xiao et al.).
Neither Vaughan et al., Torney et al., Taylor-Smith, Tseng et al., nor admissions of applicant have not been found to teach using glycidyl methacrylate or other analogous acrylate epoxides.
Xiao et al., in paragraph [0155], teach:
[0155] Examples of curable resin compositions that can be used with the curable photochromic coating compositions according to the present invention include, but are not limited to: curable resin compositions comprising epoxide functional polymer (e.g., (meth)acrylic polymers containing residues of glycidyl (meth)acrylate and epoxide reactive crosslinking agent (e.g., containing active hydrogens, such as hydroxyls, thiols and amines); and curable resin compositions comprising hydroxy functional polymer and capped (or blocked) isocyanate functional crosslinking agent. (Emphasis added)
In view of the above presentation, it would have been quite obvious to one of ordinary skill in the art at the time of the invention to have modified to the method of Vaughan et al., Torney et al., Taylor-Smith, Tseng et al., and admissions of applicant by substituting other epoxide functional polymers with glycidyl (meth)acrylate as such would have the benefit of being a “curable photochromic coating”.
In view of the well-developed state of the art, said ordinary artisan would have been amply motivated and would have had a most reasonable expectation of success.
In view of the above presentation and in the absence of convincing evidence to the contrary, claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0276578 A1 (Vaughan et al.) in view of US 8,647,644 B1 (Torney et al.), US 5,739,180 (Taylor-Smith), US 2003/0210455 A1 (Tseng et al.), and admissions of applicant as applied to claims 1, 3, 7, 9, 11-13, 31, 32, 41, 45, 47, 54, 59-62 and 64 above, and further in view of US 2012/0132870 A1 (Xiao et al.).
Claim(s) 46 is rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0276578 A1 (Vaughan et al.) in view of US 8,647,644 B1 (Torney et al.), US 5,739,180 (Taylor-Smith), US 2003/0210455 A1 (Tseng et al.), and admissions of applicant as applied to claims 1, 3, 7, 9, 11-13, 31, 32, 41, 45, 47, 54, 59-62 and 64 above, and further in view of Escorihuela et al. (2012), (Escorihuela et al., Development of oligonucleotide microarrays onto Si-based surfaces via thioether linkage mediated by UV irradiation, Bioconjug Chem., 2012 Oct 17;23(10):2121-8. doi: 10.1021/bc300333a. Epub 2012 Sep 28).
See above for the basis of the rejection as it relates to the teachings of Vaughan et al., Torney et al., and admissions of applicant.
Neither Vaughan et al., Torney et al., nor admissions of applicant have been found to teach detection of the homogenized biomolecules via a microarray.
Escorihuela et al., teach “Development of Oligonucleotide Microarrays onto Si-Based Surfaces via Thioether Linkage Mediated by UV Irradiation”.
Escorihuela et al., teach in their abstract:
ABSTRACT: Selective covalent immobilization of thiolated oligonucleotides onto an epoxy-functionalized silicon-substrate can be achieved via light radiation (365 nm). Following this approach, thiol-modified oligonucleotide probes were covalently
attached as microarrays, reaching an immobilization density of 2.5 pmol·cm−2, with a yield of 53%. The developed method presents the advantages of spatially controlled probe anchoring (by means of using a photomask), direct attachment without using cross-linkers, and short irradiation times (10 min). Hybridization efficiencies up to 65%, with full complementary strands, were reached. The approach was evaluated by scoring single nucleotide polymorphisms with a discrimination ratio around 15. Moreover, sensitive and selective detection of bacterial Escherichia coli was demonstrated.
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Escorihuela et al., at page 2121, left column, first paragraph, teach:
The development of high-performance methods for the sensitive and selective detection of DNA and RNA targets has become a key point in biomedical studies. Special
emphasis has been focused on DNA microarrays, as they allow continuous, fast, sensitive, and selective detection of DNA hybridization. (Emphasis added)
In view of the above presentation, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the methods of Vaughan et al., Torney et al., and admissions of applicant so to include the formation of a microarray on an epoxy-functionalized silicon-substrate. Said ordinary artisan would have been motivated to have done so as such methods were recognized in the art as being “high performance methods”.
In view of the above presentation and in the absence of convincing evidence to the contrary, claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0276578 A1 (Vaughan et al.) in view of US 8,647,644 B1 (Torney et al.), US 5,739,180 (Taylor-Smith), US 2003/0210455 A1 (Tseng et al.), and admissions of applicant as applied to claims 1, 3, 7, 9, 11-13, 31, 32, 41, 45, 47, 54, 59-62 and 64 above, and further in view of Escorihuela et al. (2012), (Escorihuela et al., Development of oligonucleotide microarrays onto Si-based surfaces via thioether linkage mediated by UV irradiation, Bioconjug Chem., 2012 Oct 17;23(10):2121-8. doi: 10.1021/bc300333a. Epub 2012 Sep 28).
Conclusion
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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.