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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 4 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation 50 degrees or less, and the claim also recites less than 40, less than 30, or less than 25 degrees, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 8-10, 13, 14, 19, 20, 23, 48, and 49 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.
The number of coating layers sought is indefinitely defined herein.
The recitation of claim 8 to “at least two of the said one or more coating layers…” is indefinitely provided for herein.
The initial recitation as in claim 1 to “one or more coating layers” does not necessitate at least two.
By this, it appears that Applicant intends to recite something on the order of –
“…wherein the one or more coating layers comprise at least two coating layers, and the at least two coating layers comprise…”
Similarly in claims 9, 10, 14, 19 and 20, the recitation “the coating layers” lacks proper antecedent basis in the claims as the initial, established recitation is to “one or more coating layers.”
Applicant may desire to recite “said one or more coating layers comprise one or more polyelectrolytes and/or one or more poly(amino acids)”
Or, Applicant may desire to recite “…wherein the one or more coating layers comprises a plurality of coating layers, and the plurality of coating layers comprise…”
Claim 13 appears to be desired as “…wherein at least one of said plurality of layers comprises poly(allylamine),” however, clarification is required.
Claims 19 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.
With regard to claim 48, the recitation “the outer layer” lacks proper antecedent basis in the claims. Examiner notes that such terminology first appears in claim 47, however, claim 47 has an issue of clarity as discussed below, and claim 48 does not depend from claim 47.
Clarification is required.
Claims 19 and 20 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.
The number and type of layers positively provided are indefinitely defined herein.
The recitations (similarly found in both of cls. 19 and 20) to “a first layer and when present…” and “a second layer when present…” are indefinitely understood.
The claim both sets forth a positive provision to inclusion of a first and second layer, and also sets forth a conditional (i.e. non-positive) provision to their inclusion by way of the “…and when present” in which the conditional recitation is not understood as it speaks away from a positive inclusion of first and second layers.
It would appear that Applicant should remove the conditional “when present” recitations in these claims and instead, positively establish the desired stacked arrangement of first and second layers, and desired repeated stacks of subsequent sets of first and second layers. This likewise coincides with the sought “odd” and “even” numbered layers, which are indefinitely set forth herein as it is unclear how the layers are “numbered” or stacked so as to clearly and positively establish a designation of “odd” and “even” therewith.
The present recitation does not clearly set this forth, mere discussion to n being from 0 to 300 does not set forth the metes and bounds of a layered arrangement of a multitude of the first and second layers, and notably, the second layer itself is without particular constitution to the first layer.
Clarification is required.
Claim 26 is 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.
The recitation is indefinitely understood as the terms “the ratio” and “the percentage” lack proper antecedent basis in the claim.
Claim 27 is 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.
The recitation to “the thickness” lacs proper antecedent basis in the claims.
Further, A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 26 recites the broad recitation 1nm to 450nm, and the claim also recites 3 to 100nm, 3 to 30nm, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 31-33, 35, and 37-39 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.
The recitations of the claims are indefinitely understood as the base claim is drawn to a coated substrate, and which is the sole independent claim of the set, however, herein the claims are codified under the preamble of the capillary tube or the microfluidic channel (as well as in “the capillary tube” [alone]).
Clarification is required.
Further, A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 37 recites the broad recitation of greater than 90% followed by greater than or equal to 95%, which is a narrower recitation thereof.
This is similarly seen in claims 38 and 39 with respect to the seconds, and months, respectively.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 47 is 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.
The recitation of “the coating layers” lacks proper antecedent basis in the claims as the claims previously establish one or more coating layers.
By this, it appears that Applicant intends to recite “…wherein the one or more coating layers comprise a plurality of coating layers, and wherein the plurality of coating layers comprise an outer layer (i.e. at least one of the plurality of layers is an outer layer) comprising…”
Clarification is required.
Further, A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 49 recites the broad recitation of n is at least 10, followed by 2 to 20 or n between 2 and 100, which is a narrower recitation thereof.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 26 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 26 sets forth a particular material of construction to the glass, however, glass is not necessitated by the claims. Independent claim 1 sets forth alternative choices of glass, metal, ceramic, or polymer. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Herein, it appears that Applicant intends to recite “the coated substrate according to claim 1, wherein the substrate comprises glass,” and a further dependent claim thereto that recites “…wherein said glass comprises borosilicate glass…”
Claim 33, 35, and 37 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 33 in the last recitation sets forth a capillary tube, however, a capillary tube is not necessitated as an alternative choosing of a capillary tube or a microfluidic channel is provided. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claims 38 and 39 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 38 and 39 sets forth a capillary tube, however, a capillary tube is not necessitated as an alternative choosing of a capillary tube or a microfluidic channel is provided. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 8-10, 13, 27, 29-31, 37-39, and 47 as best understood as seen above in the above-cited rejections of claims under 35 USC 112 2nd/b, is/are rejected under 35 U.S.C. 102a1 as being anticipated by Zhai et al. (US 2007/0104922).
Zhai discloses superhydrophobic coatings (abstract). With regard to claim 1, Zhai discloses a coated substrate comprising a substrate comprising one or more of glass (par.[0051]), metal, ceramic, and polymer (par.[0061]); a coating, the coating comprising one or more coating layers wherein at least one of the one or more coating layers comprise carboxylate, amine, polycarbonate, or polyamine function, or combinations thereof (par.[0049]). With regard to claim 2, Zhai discloses the contact angle of a biological fluid on the coated surface is less than 50 degrees or less, 50, less than 40, less than 30, or less than 25 degrees (par.[0077]), Examiner further asserts that a biological fluid is not a positively claimed element of the device, wherein it appears Applicant intends to provide a particular hydrophilicity to the claimed substrate, and which is likewise disclosed by Zhai. With regard to claim 3, the recitation is drawn to procedural steps that are not afforded patentable weight in a device claim and intended use recitations that are not afforded patentable weight; further, as Zhai commensurately discloses a structured and arranged coated substrate as claimed, the coated substrate of Zhai is said to be fully capable thereof in as much as recited and required herein. With regard to claim 4, the biological fluid is not a positively claimed element of the device and is drawn to an intended workpiece not afforded patentable weight. With regard to claims 8 and 9, Zhai discloses that at least two of the one or more coating layers comprise carboxylate, amine, polycarbonate, or polyamine function, or combinations thereof, and wherein the coating layers comprise one or more polyelectrolyte and/or one or more poly(amino acids)(pars.[0043-0045]). With regard to claim 10, Zhai discloses wherein the coating layers comprise one or more anionic polyelectrolytes and one or more cationic polyelectrolytes (par.[0036,0052]). With regard to claim 13, Zhai discloses wherein at least one of the coating layers comprises poly(allylamine) (par.[0049]). With regards to claims 19, 20, 23, and 49, Zhai disclose multilayered arrangements including first layer in contact with the substrate, and a second layer (first layer being anionic polyelectrolyte and second layer being cationic polyelectrolyte; par.[0052]), and provides examples showing a wide range of layers thereof providing multiple first and second layers in various embodiments (including from 2 to 100 for ‘n’) (pars.[0062-0079]), with both odd and even numbered, and which coincide with the chosen ‘n’ integral and stacked arrangement as best understood herein. With regard to claim 27, Zhai discloses the thickness of the coating is as claimed (par.[0005]). With regard to claim 29, the recitation is drawn to a process recitation not afforded patentable weight in a device claim, and wherein Zhai also provides for such spraying (par.[0035]). With regards to claims 30 and 32, Zhai discloses that the substrate comprises a capillary tube or microfluidic channel, and wherein the coating coats the inner surface of the capillary tube or microfluidic channel (par.[0037]). With regards to claims 37-39, the recitations are drawn to process recitations not afforded patentable weight in a device claim. With regard to claim 47, Zhai discloses the coating layers comprise an outer layer comprising anionic polyelectrolyte (pars.[0036,0043-0045,0052] such as seen with polyelectrolyte with polyanion through sulfonated polystyrene, and as in a polyelectrolyte with a carboxylate group). With regard to claim 48, Zhai discloses the outer layer comprises poly(acrylic acid) (par.[0036]).
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.
Claim(s) 14, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhai in view of Yang et al. (USPN 6,326,083), hereafter Yang.
Zhai has been discussed above.
Zhai discloses one or more anionic polyelectrolyte layers and one or more cationic polyelectrolyte layers (par.[0052]), but Zhai does not specifically disclose wherein the coating layers comprise one or more anionic poly(amino acids) and one or more cationic poly(amino acids).
Yang discloses various hydrophilic protein adsorption resistant coatings for microfluidic devices, and including polyamino acids applied as coatings therefor, including amino acid- poly(ethylene glycol) (abstract, lines 10-42, col. 2, lines 36-67, col. 8, lines 19-32, col. 9, for example).
It would have been obvious to one of ordinary skill in the art to modify Zhai so as to provide the coating layers comprise one or more anionic poly(amino acids) and one or more cationic poly(amino acids) such as suggested by the analogous art of Yang to hydrophilic protein resistant coatings for microfluidic devices in order to provide a surface coating arrangement that is particularly useful in biosensing applications, as likewise desired by Zhai (par.[0037]).
Claim(s) 26, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhai in view of Minagawa et al. (US 2019/02333555), hereafter Minagawa.
Zhai has been discussed above.
Zhai discloses a glass substrate, but does not disclose borosilicate glass as in cl. 26.
Minagawa discloses hydrophilic substrates in which a glass substrate, such as in borosilicate glass was coated to provide a hydrophilic substrate (par.[0043], for example).
It would have been obvious to one of ordinary skill in the art to modify Zhai to provide a borosilicate glass substrate such as taught by the analogous art of Minagawa to hydphilic coatings applied to substrates in which borosilicate glass represents an obvious alternative choosing to a particular type of glass to that used in Zhai that would have a reasonable expectation of success therein for likewise providing a substrate to be coated and made hydrophilic.
Claim(s) 31, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhai in view of Seyoum et al. (US 2019/0083977), hereafter Seyoum.
Zhai has been discussed above.
Zhai does not specifically disclose that the capillary tube or microfluidic channel comprises glass.
Seyoum discloses a microfluidic device coated with hydrophilic films and wherein the microfluidic channel comprises glass (abstract, par.[0137]).
It would have been obvious to one of ordinary skill in the art through to modify Zhai to provide the capillary tube or microfluidic channel comprising glass such as suggested by the analogous art of Seyoum to a microfluidic device coated with hydrophilic coatings for medical diagnostics as a suitable material of construction that would likewise be appreciated in Zhai which also contemplates usage with microfluidic channels and biosensors (par.[0037]) and would have a reasonable expectation of success therein.
Claim(s) 33, 35, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhai in view of Seyoum.
Zhai has been discussed above.
Zhai disclosed application with a microfluidic channel (par.[0037]), but does not specifically disclose the dimenions as in cls. 33 and 35.
Seyoum discloses microfluidic channels coated with hydrophilic layers, and wherein the microfluidic channel dimensions are not particularly limited as long as a reliable flow of the sample is assured (par.[0029]).
It would have been obvious to one of ordinary skill in the art to modify Zhai so as to provide a microfluidic channel dimensioned as recited in claims 33 and 35 such as suggested by the analogous art of Seyoum, in which where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation, and wherein choosing of such dimensions is drawn to routine engineering optimization to dimensioning the microfluidic channel thereto so as to optimize for the fluid flow therethrough for a given assay and/or a given passing fluid. See also MPEP 2144.05 II.
Further, such modification is drawn to obvious engineering optimization for the reasons discussed above and absent a showing of a criticality or unexpected results arising otherwise.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NEIL N TURK/ Primary Examiner, Art Unit 1798
Prosecution Insights