DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 2, 6, 10 – 11, 17, 21, 31 – 33, 35, 39, 44, 47, 53 and 114 in the reply filed on February 27, 2026 is acknowledged.
Claims 1, 2, 6, 10 – 11, 17, 21, 31 – 33, 35, 39, 44, 47, 53, 59 – 64, 67, 74, 88 – 89, 91, 95, 100, 103 and 114 are pending; claims 59 – 64, 67, 74, 88 – 89, 91, 95, 100 and 103 are withdrawn as non elected subject matter; claims 1, 2, 6, 10 – 11, 17, 21, 31 – 33, 35, 39, 44, 47, 53 and 114 have been considered on the merits.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on December 15, 2023 and June 27, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 6 is objected to because of the following informalities:
In claim 6, “1,2-0-dilauryl-rac-glycero-3-glutaric acid-(6-methyl-resorufin) ester” should be spelled “1,2-O-dilauryl-rac-glycero-3-glutaric acid-(6-methyl-resorufin).”
Appropriate correction is required.
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.
Claim 2 is 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.
Claim 2 recites “a system for optically determining an amount of color change.” However, the specification fails to describe any corresponding structure to support the claimed limitation. The specification fails to describe any particular system, nor does it even indicate any system that is known in the art for this purpose can be used. In paragraph 0019 of the published application, the specification states “color may be detected visually or the device may…be used in a system for optically determining the amount of color or change,” however no further disclosure is made pertaining to any system or structure. Merely restating a function associated with a means-plus-function limitation without more description of the means that accomplish the function fails to provide adequate written description under section 112(a) (MPEP 2181 (IV)).
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 1, 2, 6, 10 – 11, 17, 21, 31 – 33, 35, 39, 44, 47, 53 and 114 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 and its dependents are drawn to a device however the claims fail to set force any particular piece of equipment, machine or tool designed to serve a special purpose or perform a special function. That is, since the specification does not define “device,” the term is interpreted by its plain language meaning. Rather, the claims recite a collection of reagents in the context of “layers” whereby the various reagents are not within any particular container or designated state (e.g., solid, liquid, gas). In this regard, it is unclear if physical limitations are required to meet the various layers that make up the claimed device or if the “layers” are an intended use or arrangement of the various reagents. For purposes of examination, the claims are interpreted to be a collection of reagents wherein they may be used in layers.
Claim 2 is indefinite for reciting “a system” because the term is not adequately defined by the claim language or specification. It is unclear if the “system” is a mechanical machine, a reagent composition, or mere mental observation, e.g., looking at a color change. Moreover, the specification fails to disclose any structure, material or act for performing the recited function of “determining an amount of color change.” Clarification is required.
In claim 10, the recitation of “(Canceled)” renders the claim indefinite.
In claim 21, the phrase “support matrix” renders the claim indefinite as is not adequately defined by the claim language or specification. While the specification discloses examples of components that are included in a support matrix, the term is not defined by these examples, making it unclear what may or may not be included in the device to meet the limitation.
Claim 31 is confusing in that it is unclear if the isolation layer or the non-ionic surfactant is “soluble in an alcohol solvent.”
Claims 35 and 39 are indefinite for reciting both “at least one of” and “each independently further comprises” because it is unclear whether one or both layers require the bile salts and surfactants, respectively. For purposes of examination, the claims are interpreted to require one of the isolation or indicator layers to further include the one or more bile salts and surfactants.
In claim 2, the claim limitation “a system for optically determining an amount of color change” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Prong A. The claim limitation uses the term “a system for” that is a generic placeholder for performing the claimed function of “optically determining an amount of color change.” (MPEP 2181 (I)(A)). The claimed “system” does not limit the scope of the claim to any specific manner or structure for performing the claimed function and the specification fails to disclose any single corresponding structure of the means (system).
Prong B. The “system” is modified by functional language, “for optically determining an amount of color change.”
Prong C. The term “system” is not modified by sufficient structure, material or acts for performing the claimed function. The specification fails to provide a description sufficient to inform one of ordinary skill in the art that the term denotes any particular structure; (2) general and subject matter specific dictionaries do not provide evidence that the term has achieved recognition as a noun denoting structure; and/or (3) the prior art does not provide evidence that the term is an art-recognized structure to perform the claimed function.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claims 1, 2, 6, 10 – 11, 17, 21, 32 – 33, 35, 39, 44, 47, 53 and 114 are rejected under 35 U.S.C. 103 as being unpatentable over Huth et al. (US 2006/0121549, IDS 06.27.2024, USPAB #2).
Regarding claim 1, Huth teaches a device for determining pancreatic lipase in an animal sample (detecting presence or amount of), the device comprising multilayers of reagents (abstract, page 1) wherein the reagents include buffers, colipase and chromogenic substrate (0011-0014, examples, claims). Although the reference does not expressly teach three distinct layers as claimed, Huth teaches that one “of skill in the art will recognize that other combinations of reagents in various layers are also possible” (0045), suggesting the components of the layers can be rearranged without modifying the operation and effect of the device. In this regard, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to modify and rearrange the various layers of Huth as a matter of routine practice and with a reasonable expectation for successfully obtaining a device for detecting presence of pancreatic lipase in an animal sample (MPEP 2144.04 (II)(IV)(A) and (C)).
Regarding claim 2, the device may further include a system for the optical determination of color change in the mixture of sample, colipase and chromogenic substrate (abstract, 0011 – 0014, claim 1).
Regarding claim 6, the chromogenic substrate is DGGR (0011-0014, 0016, examples, claim 13).
Regarding claims 10, 11 and 17, the buffer has a pH of 7 – 9 (0032, example 2, claim 3); non-reactive detergent (or surfactant) (0044 – 0045, example 2) and colipase (example 2).
Regarding claim 21, the device may include a support (or support matrix) (0042, 0046).
Regarding claims 32 - 33, the DGGR reagent may further include an acidic buffer with a pH of 3.5 – 4.5 (0032).
Regarding claims 35 and 39, the reagents may further include one or more bile salts and non reactive detergents (or surfactants) (p.3, examples).
Regarding claim 44, Huth teaches a subbing layer can be included to aid in bonding the reagent layer to the support (0046) which is the same function as a primer layer as defined by applicant (specification, para 0061).
Regarding claim 47, the device further comprises optically transparent sections (substrate) (0027, example 2).
Regarding claim 53, the buffer may further include one or more bile salts and calcium chloride (0014, 0035, example 2).
Regarding claim 114, Huth teaches the device in a kit with instructions for use (claim 32).
Although the reference does not expressly teach each of the layers as claimed, Huth teaches that one “of skill in the art will recognize that other combinations of reagents in various layers are also possible” (0045), suggesting the components of the layers can be rearranged without modifying the operation and effect of the device. In this regard, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to modify and rearrange the various layers of Huth as a matter of routine practice and with a reasonable expectation for successfully obtaining a device for detecting presence of pancreatic lipase in an animal sample (MPEP 2144.04 (II)(IV)(A) and (C).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Huth et al. (US 2006/0121549, IDS 06.27.2024, USPAB #2) in view of Gonzalez et al. (2022).
Huth teaches a device for determining pancreatic lipase in an animal sample (detecting presence or amount of), the device comprising multilayers of reagents (abstract, page 1) wherein the reagents include buffers, colipase, chromogenic substrate, and a support (or support matrix) (0011-0014, 0042, 0046, examples, claims). The support may be polyvinylpyrrolidone (0038) and non-reactive detergents (or non-ionic surfactants) (0044 – 0045, example 2).
Huth does not teach the non-reactive detergents require a Hydrophilic-Lipophilic Balance (HLB) between about 15-18 or to be soluble in an alcohol solvent. However, detergents having these characteristics were commonly used in the art as a matter of routine practice and experimentation. In support, Gonzalez teaches surfactants like Tergitol™ 15 (surfactant disclosed by applicant, para 0028, 0056, 0098) for use in separating lipase from samples (abstract, sections 2.4, 3.1, 3.3, conclusion). As such, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to use commonly known and used surfactants for lipase separation and assays, with a reasonable expectation for successfully obtaining an effective device for determining lipase in an animal sample.
Although the reference does not expressly teach distinct layers as claimed, Huth teaches that one “of skill in the art will recognize that other combinations of reagents in various layers are also possible” (0045), suggesting the components of the layers can be rearranged without modifying the operation and effect of the device. In this regard, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to modify and rearrange the various layers of Huth as a matter of routine practice and with a reasonable expectation for successfully obtaining a device for detecting presence of pancreatic lipase in an animal sample (MPEP 2144.04 (II)(IV)(A) and (C)).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
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 1, 2, 6, 10 – 11, 17, 21, 32 – 33, 35, 39, 53 and 114 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 21, 29 and 35 – 39 of U.S. Patent No. 7514255 (IDS 06.27.2024, USP #3). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Regarding claims 1, 2 and 114, the patent claims a device for detecting the presence or amount of pancreatic lipase in an animal blood sample, the device being suitable for kit form, the device comprising: (a) a first compartment containing a first liquid reagent comprising a chromogenic lipase substrate, a second compartment containing a second liquid reagent comprising a surface active agent, and an optional third compartment, wherein at least one of the first reagent or the second reagent comprises a colipase, and (b) a system for optically determining the amount of a development of a color change in the mixture of the sample (claim 1).
Regarding claim 6, the chromogenic lipase substrate is 1,2-O-dilauryl-rac-glycero-3-glutaric acid-(6-methyl-resorufin)ester (DGGR) (claim 10.
Regarding claims 10, 11 and 17, the pH of the second reagent is between about 7.5 and 9.0 (claim 3); comprises a surfactant (claim 1) and colipase (claim 18).
Regarding claim 21, the reagents include a support (container) (claim 34, 39).
Regarding claims 32 and 33, a reagent may further have an acidic buffer with a pH of 3.5 – 4.5 (claim 35, 37).
Regarding claims 35, 39 and 53, the reagents may include bile salts, surfactants and/or calcium (claim 1, 11, 21, 35).
Although the reference does not expressly teach distinct layers as claimed, it teaches that one “of skill in the art will recognize that other combinations of reagents in various layers are also possible” (col.7 line 60 – 64) suggesting the components of the layers can be rearranged without modifying the operation and effect of the device. In this regard, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to modify and rearrange the various layers of the issued patent as a matter of routine practice and with a reasonable expectation for successfully obtaining a device for detecting presence of pancreatic lipase in an animal sample (MPEP 2144.04 (II)(IV)(A) and (C)).
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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/RUTH A DAVIS/ Primary Examiner, Art Unit 1699
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