Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group II (claims 16-17 and 19-36) in the reply filed on 3/2/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claim 36 is objected to because of the following informalities.
Claim 36 recites: “wherein the surface has a perimeter has one or more recessed regions extending partially or entirely through the substrate.” The claim should be changed to: --wherein the surface has a perimeter that has one or more recessed regions…….--
Appropriate correction is required.
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 20, 21, and 30 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.
Applicant’s claim 20 recites that the treating time is reduced by greater than about 10%. It is not clear which treating is being referred to—the treatment to increase hydrophilicity (as in subsection a) of claim 16, or the treatment to desiccate (as in subsection b) of claim 16). For examination purposes, the claim is interpreted to be referring to the treatment to desiccate.
Applicant’s claim 21 recites wherein the treating comprises lyophilization. It is not clear which treating is being referred to—the treatment to increase hydrophilicity (as in subsection a) of claim 16, or the treatment to desiccate (as in subsection b) of claim 16). For examination purposes, the claim is interpreted to be referring to the treatment to desiccate.
Claim 30 recites method further comprises “removing the dried reagent:substrate complex from the solid phase substrate”. It is not clear how the reagent:substrate complex is removed from the solid phase substrate when the complex includes the substrate. For examination purposes, the claim will be interpreted as: removing the dried reagent from the substrate.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16, 17, 20-31, 35, 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 3 of copending Application No. 17/364,615 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the reference application encompasses the present claim 16 (wherein the lyophilizing step (d) in claim 1 of the reference application is the same as step (b) in the present claim 16 reciting a step to desiccate the aliquot.)
The present claim 17 recites that a treating time required to at least partially desiccate the aliquot and form the dried reagent:substrate complex is reduced as compared to treating time required to form the dried reagent:substrate complex on an untreated surface.
Examiner notes that the treatment to the surface of a substrate to increase hydrophilicity is taught by Montagu (see discussion above regarding claim 16), and thus the properties of the surface would have the same properties of requiring less time to desiccate an aliquot to form the dried reagent: substrate complex.
The present claim 20 recites that the treating time [to desiccate] is reduced by greater than about 10%. This falls within a workable or optimum range for the invention as discussed above. Discovering a workable or optimum range for a known limitation, where the general conditions of the claim is taught, such as here, requires ordinary skills in the art, and thus would have been obvious.
The present claim 21 recites wherein the treating [to desiccate] comprises lyophilization. See step (c) in claim 1 of the reference.
The present claim 22 recites freezing the aliquot prior to lyophilization. Examiner notes that, as well-known in the art, lyophilization is a method of removing water from substances by first freezing them and then reducing the surrounding pressure to allow ice to convert directly into vapor, bypassing the liquid phase. Thus it would have been obvious to one skilled in the art that a material that has previously been frozen, such as in storage, may also be lyophilized.
The present claim 23 recites that the dried reagent:substrate complex has a convex upper surface and a substantially flat bottom surface.
One skilled in the art would have recognized that other configurations, such as nonplanar wells as well-known in the assay art, can be used, which would encompass the dried reagent:substrate complex having a convex upper surface [due to a meniscus prior to freeze-drying] and a substantially flat bottom surface.
The present claim 24 recites that the dried reagent:substrate complex has a concave upper surface and a substantially flat bottom surface.
One skilled in the art would have recognized the predictable outcome of using a planar surface and deposited spots of reagents, as well-known in the assay art, which would encompass a dried reagent:substrate complex that would have a concave upper surface and a substantially flat bottom surface.
The present claim 25 recites that the dried reagent:substrate complex has a height that is reduced as compared to a reagent:substrate complex formed on a surface that has not been treated to increase hydrophilicity.
Examiner notes that the treatment to the surface of a substrate to increase hydrophilicity is taught by claim 1 of the reference application, and thus the properties of the surface would have the same properties of the dried reagent:substrate complex having a height that is reduced as compared to a reagent:substrate complex formed on a surface that has not been treated to increase hydrophilicity.
The present claim 26 recites that the dried reagent:substrate complex is defined by a maximum height and an outer diameter, wherein the maximum height is equal to or less than about 90% of the outer diameter.
This falls within a workable or optimum range for the invention discussed above. Discovering a workable or optimum range for a known limitation, where the general conditions of the claim is taught, such as here, requires ordinary skills in the art, and thus would have been obvious.
The present claim 27 recites that the dried reagent:substrate complex has a disc shape.
It would have been predictable to one skilled in the art that the substrate can be varied as desired and the reagent spot can be in various forms. It would have been obvious to one skilled in the art that the dried reagent:substrate complex having a disc shape is a design choice, as a configuration that can be varied, and results in a predictable outcome.
The present claim 28 recites that the dried reagent:substrate complex comprises a moisture content of less than about 10%.
This falls within a workable or optimum range for the invention discussed above. Discovering a workable or optimum range for a known limitation, where the general conditions of the claim is taught, such as here, requires ordinary skills in the art, and thus would have been obvious.
The present claim 29 recites that 5000 pl or less of the liquid reagent is deposited on the surface.
This falls within a workable or optimum range for the invention discussed above. Discovering a workable or optimum range for a known limitation, where the general conditions of the claim is taught, such as here, requires ordinary skills in the art, and thus would have been obvious.
The present claim 30 recites method further comprises removing [the dried reagent from the substrate]. One skilled in the art would have recognized that the dried can be removed from the substrate upon providing a fluid and removing the fluid from the substrate, as desired during an assay.
The present claim 31 recites that the hydrophilicity of the surface is increased by treating the surface to reduce a contact angle of the liquid aliquot with the surface to less than about 90 degrees.
This falls within a workable or optimum range for the invention discussed above. Discovering a workable or optimum range for a known limitation, where the general conditions of the claim is taught, such as here, requires ordinary skills in the art, and thus would have been obvious.
The present claim 35 recites that the solid phase substrate comprises a porous artificial membrane, a porous polymer, or a glass fiber membrane.
Claim 3 of the reference recites that the substrate comprises glass or polymers. It would have been predictable to one skilled in the art that the invention of the reference application can be used in a variety of substrate well-known in the art, including a porous polymer.
The present claim 36 recites that the surface has a perimeter [that] has one or more recessed regions extending partially or entirely through the substrate.
It would have been predictable by one skilled in the art that the substrate can be varied as desired and the reagent spot can be in various forms. The surface having a perimeter that has one or more recessed regions extending partially or entirely through the substrate is a design choice that results in a predictable outcome.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 16-17, 21, 22, 24, 25 and 30 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 20110207621 (hereinafter “Montagu”).
Applicant’s claim 16 recites a method generating a dried reagent:substrate complex, comprising:
a) depositing an aliquot of a liquid reagent on a solid phase substrate having a surface for contacting the liquid reagent to form a reagent:substrate complex,
wherein the surface is treated to increase hydrophilicity of the surface; and
b) treating the reagent:substrate complex under conditions to at least partially desiccate the aliquot, thereby generating the dried reagent:substrate complex.
Montagu discloses these elements as follows.
Montagu teaches that the surface of the porous material or sub-channels is a hydrophilic surface for supporting reagent material dried thereon, and has a releasable property for the reagent when contacted with liquid, such that when a dried layer of reagent material disposed on the hydrophilic surface is exposed to buffer liquid flowing into the reagent passage enables the reagent material to be liquefied in situ, to create the relatively viscous reagent liquid that is subject to the plug-like flow. Para. 0051.
Proteins in solution (as well as other assay reagents) including sample conditioning agents are commonly dried for storage by simple evaporation, spray dry or freeze-dry processes onto a hydrophilic surface to preserve their biological properties. The proteins (or other reagents) may be reconstituted by later fluidization to restore their activity. The hydration process is accelerated when the material is presented as a thin layer to the hydrating fluid. Para. 0164.
As most injection-moldable plastics for cassettes such as polycarbonate or COC are hydrophobic, it is customary to coat a protein storage chamber of a cassette with a layer of "sacrificial" protein to make the wall hydrophilic. Para. 0165.
Montagu discloses that a set of substantially parallel flow sub channels may be formed by a nest of side-by-side tubes or tube-like features to produce the plug-like flow, and they may define a hydrophilic surface for carrying dried reagent. Such structure may be molded or extruded of hydrophobic material and post-treated to be hydrophilic. The solid that immobilizes the capture reagent in the reactive chamber may be of forms other than a planar surface and the capture reagent may be in forms other than deposited spots. An assay reagent in liquid form may be introduced and stored in a cassette and subjected to the plug flow and mixing actions described. Instead of radiation-stimulated fluorescence, cassettes may be based on other detection schemes, for instance luminescence or electrochemical luminescence. Para. 0337.
Applicant’s claim 17 recites that a treating time required to at least partially desiccate the aliquot and form the dried reagent:substrate complex is reduced as compared to treating time required to form the dried reagent:substrate complex on an untreated surface.
Examiner notes that the treatment to the surface of a substrate to increase hydrophilicity is taught by Montagu (see discussion above regarding claim 16), and thus the properties of the surface would have the same properties of requiring less time to desiccate an aliquot to form the dried reagent: substrate complex.
Applicant’s claim 21 recites wherein the treating [to desiccate] comprises lyophilization. Examiner notes that freeze-drying (as disclosed by Montagu in paragraph 0164) is the same as lyophilization, and the dried reagent, such as disclosed in paragraph 0337 by Montagu, is understood to be dried by such methods as lyophilization.
Claim 22 recites freezing the aliquot prior to lyophilization. Examiner notes that, as well-known in the art, lyophilization is a method of removing water from substances by first freezing them and then reducing the surrounding pressure to allow ice to convert directly into vapor, bypassing the liquid phase. Thus it would have been obvious to one skilled in the art that a material that has previously been frozen, such as in storage, may also be lyophilized.
Applicant’s claim 24 recites that the dried reagent:substrate complex has a concave upper surface and a substantially flat bottom surface.
Montagu teaches that the structure [substrate] may be molded or extruded of hydrophobic material and post-treated to be hydrophilic. The solid that immobilizes the capture reagent in the reactive chamber may be of forms other than a planar surface and the capture reagent may be in forms other than deposited spots. Para. 0337.
Regarding Applicant’s claim 24, one skilled in the art would have recognized that the invention utilizing a planar surface and deposited spots of reagents (such as disclosed in para. 0337 by Montagu) encompasses a dried reagent:substrate complex that would have a concave upper surface and a substantially flat bottom surface.
Applicant’s claim 25 recites that the dried reagent:substrate complex has a height that is reduced as compared to a reagent:substrate complex formed on a surface that has not been treated to increase hydrophilicity.
Examiner notes that the treatment to the surface of a substrate to increase hydrophilicity is taught by Montagu (see discussion above regarding claim 16), and thus the properties of the surface would have the same properties of the dried reagent:substrate complex having a height that is reduced as compared to a reagent:substrate complex formed on a surface that has not been treated to increase hydrophilicity.
Claim 30 recites method further comprises removing the dried reagent:substrate complex from the solid phase substrate. This is disclosed by Montague in the subsequent step of applying a fluid to the dried reagent. See paras. 0051 and 0164.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 20, 23, 26-29, 31, 35-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20110207621 (hereinafter “Montagu”).
Applicant’s claim 20 recites that the treating time [to desiccate] is reduced by greater than about 10%. This falls within a workable or optimum range for the invention as discussed above. Discovering a workable or optimum range for a known limitation, where the general conditions of the claim is taught, such as here, requires ordinary skills in the art, and thus would have been obvious.
Applicant’s claim 23 recites that the dried reagent:substrate complex has a convex upper surface and a substantially flat bottom surface.
Montagu teaches that the structure [substrate] may be molded or extruded of hydrophobic material and post-treated to be hydrophilic. The solid that immobilizes the capture reagent in the reactive chamber may be of forms other than a planar surface and the capture reagent may be in forms other than deposited spots. Para. 0337.
Regarding Applicant’s claim 23, as disclosed in paragraph 0337, Montagu teaches that various types of substrates may be used. One skilled in the art would have recognized that other configurations, such as nonplanar wells as well-known in the assay art, can be used, which would encompass the dried reagent:substrate complex having a convex upper surface [due to a meniscus prior to freeze-drying] and a substantially flat bottom surface.
Applicant’s claim 26 recites that the dried reagent:substrate complex is defined by a maximum height and an outer diameter, wherein the maximum height is equal to or less than about 90% of the outer diameter.
This falls within a workable or optimum range for the invention discussed above. Discovering a workable or optimum range for a known limitation, where the general conditions of the claim is taught, such as here, requires ordinary skills in the art, and thus would have been obvious.
Claim 27 recites that the dried reagent:substrate complex has a disc shape.
Montagu teaches that the structure [substrate] may be molded or extruded of hydrophobic material and post-treated to be hydrophilic. The solid that immobilizes the capture reagent in the reactive chamber may be of forms other than a planar surface and the capture reagent may be in forms other than deposited spots. Para. 0337.
Given that the substrate can be varied as desired and the reagent spot can be in various forms, as suggested by Montagu, the dried reagent:substrate complex having a disc shape is a design choice that can be varied as generally suggested by Montagu and also results in a predictable outcome.
Applicant’s claim 28 recites that the dried reagent:substrate complex comprises a moisture content of less than about 10%.
This falls within a workable or optimum range for the invention discussed above. Discovering a workable or optimum range for a known limitation, where the general conditions of the claim is taught, such as here, requires ordinary skills in the art, and thus would have been obvious.
Claim 29 recites that 5000 pl or less of the liquid reagent is deposited on the surface.
This falls within a workable or optimum range for the invention discussed above. Discovering a workable or optimum range for a known limitation, where the general conditions of the claim is taught, such as here, requires ordinary skills in the art, and thus would have been obvious.
Claim 31 recites that the hydrophilicity of the surface is increased by treating the surface to reduce a contact angle of the liquid aliquot with the surface to less than about 90 degrees.
This falls within a workable or optimum range for the invention discussed above. Discovering a workable or optimum range for a known limitation, where the general conditions of the claim is taught, such as here, requires ordinary skills in the art, and thus would have been obvious.
Applicant’s claim 35 recites that the solid phase substrate comprises a porous artificial membrane, a porous polymer, or a glass fiber membrane.
Montagu teaches that nitrocellulose membrane is an undesirable choice unless treated with a blocker material that reduces protein attachment such as BSA or that interferes with bonding (e.g. Tween, Triton, or Brij) or Polyethylene Glycol; similarly polystyrene is undesirable unless similarly treated. (Para. 0166). Nevertheless these membranes are well-known in the art as assay supports and Montagu suggests that they may also be used, if treated. Use of such materials in the Montagu invention would have thus been obvious as known materials for providing an assay support. Examiner notes that nitrocellulose is a porous artificial membrane, as well as a porous polymer.
Applicant’s claim 36 recites that the surface has a perimeter [that] has one or more recessed regions extending partially or entirely through the substrate.
Montague teaches that the solid that immobilizes the capture reagent in the reactive chamber may be of forms other than a planar surface and the capture reagent may be in forms other than deposited spots. Para. 0337.
Given that the substrate can be varied as desired and the reagent spot can be in various forms, as suggested by Montagu, the surface having a perimeter that has one or more recessed regions extending partially or entirely through the substrate is a design choice that can be varied as generally suggested by Montagu and also results in a predictable outcome.
Allowable Subject Matter
Claims 19 and 32-34 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter.
Regarding claim 19, it was not found in the prior art search a teaching or suggestion for the method further comprising:
freezing the aliquot to form a first homogeneous frozen layer;
depositing a second aliquot of a second liquid reagent on the first homogeneous frozen layer;
freezing the second aliquot to form a reagent laminate comprising the first homogeneous frozen layer and a second homogeneous frozen layer; and
treating the surface under conditions to at least partially lyophilize the reagent laminate, thereby generating a dried hybrid reagent:substrate complex on the substrate.
As to claim 32 (and its dependent claims 33 and 34), it was not found in the prior art search a teaching or suggestion for the method of claim 16 further comprising:
freezing the aliquot on the substrate to form a frozen aliquot before treating the surface to desiccate the aliquot,
depositing a second aliquot of a liquid reagent on the frozen aliquot to form a hybrid aliquot,
and treating the hybrid aliquot under conditions to desiccate the hybrid aliquot thereby generating a dried reagent:substrate complex on the substrate,
wherein the dried reagent:substrate complex includes a first substantially homogeneous reagent layer and a second substantially homogeneous reagent layer, the first and second substantially homogenous reagent layers being substantially unmixed with each other.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20160058893. See para. 0091 disclosing freeze-drying to be the same as lyophilizing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Montgomery whose telephone number is (571)272-0894. The examiner can normally be reached Mon-Fri, 9-5:30 PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Greg Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ann Montgomery/Primary Examiner, Art Unit 1678
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