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 .
DETAILED ACTION
Claims 1-24 are pending and under consideration in this action.
Priority
The instant claims are entitled to the effective filing date of 08/29/2019.
Claim Objections
Claims 1-2, 8, 16 and 18-19 are objected to because of the following informalities:
Claims 1-2, 8 and 18-19 recite “comprising”, on line 2, which should be replaced with “comprising:”.
Claim 16 recites “letting the Schiff reagent solution to contact”, which should be replaced with “letting the Schiff reagent solution contact” because the preposition “to” is extraneous.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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, 4, 11-12 and 21 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 claims contain 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, at the time the application was filed, had possession of the claimed invention.
Claims 1, 4, 11-12 and 21 are drawn to a genus of dry culture media that activate the galactose oxidase once water is added onto the test strip or membrane pre-embedded with a galactose oxidase and further containing the dry culture medium. The instant claims do not limit the structure of the dry culture medium in anyway. The specification does not disclose a representative number of species of the claimed genus by reduction to practice, and does not provide adequate guidance with regard to the structural features of the dry culture medium that is required to provide the recited galactose oxidase activation properties. Therefore, one of ordinary skill in the art cannot immediately envision which dry culture medium will have the required functional characteristics, and one could not conclude that Applicant was in possession of the claimed genus at the time of filing, as discussed more fully below.
For claims drawn to a genus, MPEP § 2163(3)(a)(ii) indicates the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e., structure or other physical and/ or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The instant specification does not reduce to practice any example of a dry culture medium that activates galactose oxidase once water is added onto the test strip or membrane. In example 1, the specification teaches a mucosal scrape sample collected from a subject. The scrape sample is mixed with distilled or reverse osmosis water and applied to a test strip with galactose oxidase pre-embedded at a concentration of 100U/mL. The sample is allowed to remain on the test strip for 10 minutes after which point the test strip is rinsed with additional distilled water. In a separate container, a Schiff reagent is activated in solution after which the solution is added to the test strip. The sample is allowed to remain in contact with the Schiff reagent for 1 minute after which the test strip is rinsed with water and dried in open air or in an oven. A color change (from white or colorless to magenta) is indicative of the presence of the carbohydrate marker. See [0079]. The specification does not reduce to practice a test strip or membrane comprising a dry culture medium that activates galactose oxidase once water is added.
MPEP 2163(3)(a)(ii) states that “the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation. Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date”. Considering the lack of guidance provided in the specification, one would appraise support from the state of the art to extrapolate the correlation between the dry culture medium structure and the galactose oxidase activation function.
With respect to the state of the art on activating galactose oxidase, Johnson (US 4,220,503) discloses that one problem encountered in the use of galactose oxidase is its relatively low level of enzymatic activity with some substances. For this reason activation by redox material such as ferricyanide has been proposed. See column 2 lines 59-64. Johnson teaches that a system containing immobilized galactose oxidase and ferricyanide as an activator loses activity of the enzyme rapidly, 2-3 days. Whereas the same system in the absence of ferricyanide maintains essentially constant enzyme activity over several days. See column 2 line 67 to column 3 line 4. Johnson also suggests that immobilized galactose oxidase membranes are capable of being used and reused for a period of at least 25 days even in the presence of a redox activator as long as added cupric ions are also present. See column 6 lines 32-37. Lorente-Arevalo (Chembiochem. 2023 Dec 14;24(24):e202300421), a post-filing date reference, teaches that the practical application of galactose oxidase (GalOx) has been hindered by the limited availability of active and stable biocatalysts, as well as the inherent biochemical limitations such as oxygen (O2) dependency and the need for activation. See the abstract. To utilize GalOx as a biocatalyst, Lorente-Arevalo teaches that continuous (re)activation of the enzyme is required. This involves the regeneration of its radical state in the active site through single-electron oxidants. This reactivation can be achieved through the action of sacrificial substrates or by employing radical formation catalysts in parallel reactivation reactions. See p. 1 left column first paragraph. Lorente-Arevalo teaches co-immobilizing hemoglobin as an activator alongside the enzyme in order to overcome the need for addition of soluble external activation molecules. See p. 9 the sentence bridging the left and right columns. Thus, Johnson and Lorente-Arevalo illustrate the unpredictability in the art because the references suggest that galactose oxidase can be activated by different structures, e.g. ferricyanide and hemoglobin; however, the art does not teach a dry culture medium structure capable of activating galactose oxidase once water is added.
Lacking prior art disclosure of the structure of any test strip or membrane pre-embedded with a galactose oxidase and further containing a dry culture medium that activates the galactose oxidase once water is added onto the test strip or membrane, the instant disclosure does not satisfy the written description requirement because the species disclosed do not adequately represent the substantial variation within the claimed genus. The breadth of potential structures encompassed by the claims is substantial. As evidenced by Lorente-Arevalo, there are different mechanisms by which galactose oxidase can be activated, i.e. sacrificial substrates or by employing radical formation catalysts (see p. 1 left column first paragraph). Johnson teaches activating galactose oxidase with redox material such as ferricyanide (see column 2 lines 59-64.). However, Johnson’s ferricyanide is not a dry culture media, and Johnson does not teach activating galactose oxidase once water is added. The instant specification does not reduce to practice any examples of dry culture media that are capable of activating galactose oxidase once water is added onto the test strip or membrane. Moreover, the specification does not identify relevant characteristics or structures associated with such activation. Consequently, one of skill could not conclude that Applicant was in possession of the claimed genus at the time the application was filed.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-24 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 term “rapidly” in line 1 of claims 1, 2, 7, 8, 18 and 19 is a relative term which renders the claim indefinite. The term “rapidly” 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. To obviate this rejection, the term “rapidly” can be deleted.
Claims 3-6, 9-17, and 20-24 depend from claim 1, 2, 7, 8, 18 or 19 and are rejected for the reason set forth above.
Claims 22 and 23 recite “The use of the screening device” in line 1, and claim 24 recites “the use of the screening kit”. Therefore, claims 22-24 are “use” claims because they do not recite any active method steps. MPEP 2173.05(q) states that “attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness”. In the instant case, claim 22 requires the use of the screening device to screen a cancerous or precancerous condition, but the claim does not set forth any steps involved in the screening process. Claim 23 depends from claim 22 and does not set forth any steps involved in the screening process. Claim 24 requires the use of the screening kit according to claim 19 to screen a cancerous or precancerous condition. However, claim 24 does not set forth any active method steps involved in the screening process.
Claim 23 recites “or ovaries cancerous or precancerous condition” in line 3, which renders the claim indefinite because in one interpretation “or ovaries cancerous or precancerous condition” encompasses ovary cancer conditions, or any precancerous condition. In a second interpretation, the claim encompasses ovary cancer or ovary precancer conditions. However, in this second interpretation the recitation “cancerous or precancerous condition” in line 3 is extraneous. To obviate this rejection, “cancerous or precancerous condition” can be deleted from line 3.
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.
Claims 1-3, 7-10, 18-20, and 22-24 are rejected under 35 U.S.C. 103 as being obvious over Shamsuddin1988 (WO 88/00702) (citation number 2 on p. 2 of the IDS filed 10/21/2024).
Claim interpretation: instant claims 1-2 are product claims that require a test strip or membrane with galactose oxidase pre-embedded, and a container with Schiff reagent (also referred to as basic fuchsin); and the Schiff reagent is required to be separated from the test strip or membrane, because claim 1 recites “the Schiff reagent solution is not initially in contact with the test strip or membrane”. The instant specification discloses that “impregnated” and “pre-embedded” are interchangeable. See [0029].
Regarding claims 1-2, Shamsuddin1988 teaches detecting precancer, cancer or other diseases comprising obtaining mucus and detecting the presence of a disaccharide marker (i.e. carbohydrate). See p. 22 amended claim 1 of Shamsuddin1988. Shamsuddin1988 teaches a galactose oxidase strip test. See p. 16 line 25. Shamsuddin1988 teaches galactose oxidase lyophilized on a cellulose filter, which Shamsuddin1988 suggests forms an impregnated (i.e. pre-embedded) test strip. See p. 17 lines 13-15. Shamsuddin1988 teaches separate containers of galactose oxidase and basic fuchsin. See p. 6 lines 20-22. Shamsuddin1988 discloses that basic fuchsin is packaged as Schiff’s reagent. See claim 19 of Shamsuddin1988.
Although Shamsuddin1988 does not explicitly teach the instantly claimed Schiff reagent solution that can be activated to contact the test strip or membrane after marker carbohydrates are oxidized by galactose oxidase, the structure of the container with Schiff reagent is capable of such activation based on the instant claim language.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to recognize that Shamsuddin1988’s separate container of Schiff reagent can be activated to contact the test strip or membrane after marker carbohydrates are oxidized by galactose oxidase, because Shamsuddin1988 teaches smearing mucus on a membrane filter (see p. 17 lines 1-2), contacting it with galactose oxidase (see p. 17 lines 5-7) and placing the membrane filter in Schiff reagent (p. 17 lines 10-12), such that the Schiff reagent contacts the membrane after galactose oxidase.
Regarding claim 3, Shamsuddin1988 teaches that at least one of galactose oxidase and basic fuchsin is microencapsulated. See p. 24 amended claim 20 of Shamsuddin1988.
Regarding claims 7-8, Shamsuddin1988 teaches a method for detecting the presence of precancer, or cancer in humans comprising: obtaining a sample of body fluid, and assaying the sample to quantitively detect the presence of the disaccharide (i.e. carbohydrate). See p. 20 claim 1. The body fluid includes large intestinal mucus. See p. 21 claim 12. Shamsuddin1988 suggests that the assay is rapid. See the abstract. Example 3 teaches smearing (i.e. applying) mucus on a piece of membrane filter. See p. 17 lines 1-2. Galactose oxidase is lyophilized on a cellulose filter prior to the test. See p. 17 lines 14-15. Galactose oxidase is in a lyophilized form when impregnated (i.e. pre-embedded) onto a porous support such as filter paper. See p. 6 lines 23-25. Shamsuddin1988 teaches placing membrane filters in Schiff reagent (i.e. contact). See p. 17 lines 10-12. Shamsuddin1988 suggests that the Schiff reagent is not initially in contact with the test strip or membrane, because Shamsuddin1988 teaches a container comprising separately packaged galactose oxidase and basic fuchsin. See p. 21 claim 14.
Shamsuddin1988 does not teach activating a container with Schiff reagent solution.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to contact the Schiff reagent with the membrane filter, as taught by Shamsuddin1988, and in the process activate a container with Schiff reagent solution adjacent to the test strip or membrane to contact the test strip or membrane. One of ordinary skill in the art would be motivated to do so because Shamsuddin1988 explicitly teaches contacting Schiff reagent solution with the membrane filter pre-embedded with galactose oxidase. There would have been a reasonable expectation of success because Shamsuddin1988 discloses that the Schiff reagent solution is separate from the membrane filter prior to the contact.
Regarding claim 9, in example 3, Shamsuddin1988 teaches saturating the impregnated test strip with deionized distilled water just before the test. See p. 17 lines 15-16. Shamsuddin1988 teaches that the galactose oxidase is in lyophilized form, which can then be wetted and contacted directly with the body fluid sample on the membrane filter. See p. 6 lines 23-25.
Regarding claim 10, Shamsuddin1988 teaches that at least one of galactose oxidase and basic fuchsin is microencapsulated. See p. 24 amended claim 20 of Shamsuddin1988.
Regarding claim 18-19, Shamsuddin1988 teaches a diagnostic kit for detecting the presence of large intestinal cancer, which comprises a container comprising separately packaged galactose oxidase, a protein-capturing membrane filter, and basic fuchsin (i.e. Schiff reagent solution). See p. 20 claim 14 of Shamsuddin1988. Shamsuddin1988 teaches galactose oxidase in a lyophilized form when impregnated (i.e. pre-embedded) onto a porous support such as filter paper. See p. 6 lines 23-25. Furthermore, Shamsuddin1988 teaches detecting precancer, or cancer in humans comprising: obtaining a sample of body fluid, and assaying the sample to quantitively detect the presence of the disaccharide (i.e. carbohydrate). See p. 20 claim 1. The body fluid includes mucus. See p. 21 claim 12. Shamsuddin1988 suggests that the assay is rapid. See the abstract.
Shamsuddin1988 does not teach a kit comprising a test strip or membrane with galactose oxidase pre-embedded. However, Shamsuddin1988 teaches a kit (see p. 20 claim 14 of Shamsuddin1988) and a membrane filter with galactose oxidase pre-embedded (see p. 6 lines 23-25).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to combine Shamsuddin1988’s membrane containing pre-embedded galactose oxidase with Shamsuddin1988’s kit. One of ordinary skill in the art would have been motivated to do so because Shamsuddin1988 suggests that preferably the galactose oxidase is in lyophilized form, especially when impregnated onto a porous support such as filter paper (p. 6 lines 23-25).
Regarding claim 20, Shamsuddin1988 teaches that at least one of galactose oxidase and basic fuchsin is microencapsulated. See p. 24 amended claim 20 of Shamsuddin1988.
Regarding claim 22, Shamsuddin1988 teaches a galactose oxidase impregnated (i.e. pre-embedded) test strip (see p. 17 lines 13-15), and a separate container of basic fuchsin (i.e. Schiff reagent solution) (see p. 6 lines 20-22). Shamsuddin1988 suggests that the structure can be used for detecting (i.e. screening) precancer, cancer or other diseases. See p. 22 amended claim 1 of Shamsuddin1988.
Regarding claim 23, Shamsuddin1988 teaches detecting the presence of large intestinal cancer (i.e. stomach cancer). See p. 21 claim 14.
Regarding claim 24, Shamsuddin1988 teaches a diagnostic kit for detecting (i.e. screening) the presence of large intestinal cancer, which comprises a container comprising separately packaged galactose oxidase, a protein-capturing membrane filter, and basic fuchsin (i.e. Schiff reagent solution). See p. 20 claim 14 of Shamsuddin1988.
Claims 1-2, 5-8, 13-19 and 22-24 are rejected under 35 U.S.C. 103 as being obvious over Shamsuddin1994 (US 5,348,860) (citation number 2 on p. 1 of the IDS filed 10/21/2024).
Regarding claims 1-2, Shamsuddin1994 teaches a kit that comprises separate containers of galactose oxidase, storage stable basic fuchsin (i.e. Schiff reagent solution). The galactose oxidase is impregnated into the same membrane filter onto which the mucus sample is applied. See column 7 lines 24-31.
Although Shamsuddin1994 does not teach the Schiff reagent solution that can be activated to contact the test strip or membrane after marker carbohydrates are oxidized by galactose oxidase as claimed, based on the instant claim language the structure of a container with Schiff reagent is capable of such activation.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to recognize that Shamsuddin1994’s separate container of basic fuchsin is a Schiff reagent that can be activated to contact the test strip or membrane after marker carbohydrates are oxidized by galactose oxidase, because Shamsuddin1994 teaches that galactose oxidase oxidizes galactose moieties (i.e. a carbohydrate) (see column 8 lines 65-66), and the presence of aldehyde sugar moieties in the thus-oxidized product can be detected using Schiff’s reagent (see column 9 lines 2-5).
Regarding claim 5, Shamsuddin1994 teaches a kit containing a capped vial containing an amount of storage-stable basic fuchsin (i.e. Schiff). See column 9 lines 55-56. Shamsuddin1994 teaches a kit that comprises separate containers of galactose oxidase, storage stable basic fuchsin (i.e. Schiff reagent solution). See column 7 lines 24-31.
Although Shamsuddin1994 does not teach the Schiff reagent solution is activated by opening a twist valve or by breaking a barrier between the Schiff reagent solution container and the test strip or membrane, Shamsuddin1994 teaches the structure of a cap barrier between the Schiff reagent the test strip or membrane. Therefore, based on the instant claim language, the Schiff reagent of Shamsuddin1994 is capable of the claimed activation.
Regarding claim 6, Shamsuddin1994 teaches storage-stable Schiff reagent solution. See column 10 line 8,
Regarding claims 7-8, Shamsuddin1994 teaches a screening method for rapidly testing a human being for a cancerous or precancerous condition comprising: obtaining mucus and assaying the sample for the presence of glycoprotein containing at least one carbohydrate. See claim 1 of Shamsuddin1994. Shamsuddin1994 teaches galactose oxidase impregnated (i.e. pre-embedded) into the same membrane filter onto which the mucus sample is applied. See column 7 lines 29-31. Shamsuddin1994 teaches smearing mucus on the membrane filter, reacting with galactose oxidase, and reacting with basic fuchsin. See column 10 lines 49-55. Shamsuddin1994 teaches that galactose oxidase oxidizes galactose moieties of glycoprotein in mucus. See column 8 lines 65-67.
Shamsuddin1994 does not teach activating a container with Schiff reagent solution.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to contact the Schiff reagent with the membrane filter, as taught by Shamsuddin1994, and in the process activate a container with Schiff reagent solution adjacent to the test strip or membrane to contact the test strip or membrane. One of ordinary skill in the art would be motivated to do so because Shamsuddin1994 explicitly teaches contacting Schiff reagent solution with the membrane filter pre-embedded with galactose oxidase. There would have been a reasonable expectation of success because Shamsuddin1994 discloses that the Schiff reagent solution is separate from the membrane filter prior to the contact.
Regarding claim 13, Shamsuddin1994 teaches a kit containing a capped vial containing an amount of storage-stable basic fuchsin (i.e. Schiff). See column 9 lines 55-56. Shamsuddin1994 teaches a kit that comprises separate containers of galactose oxidase, storage stable basic fuchsin (i.e. Schiff reagent solution). See column 7 lines 24-31.
Although Shamsuddin1994 does not teach the Schiff reagent solution is activated by opening a twist valve or by breaking a barrier between the Schiff reagent solution container and the test strip or membrane, Shamsuddin1994 teaches the structure of a cap barrier between the Schiff reagent the test strip or membrane. Therefore, based on the instant claim language, the Schiff reagent of Shamsuddin1994 is capable of the claimed activation.
Regarding claim 14, Shamsuddin1994 teaches smearing mucus on a membrane filter, and reacting with galactose oxidase for 10 minutes, which is a period of 5 to 20 minutes as instantly required. See column 10 lines 49-52.
Regarding claim 15, Shamsuddin1994 teaches smearing mucus on a membrane filter, reacting with galactose oxidase for 10 minutes, washing with deionized distilled water (i.e. removing the mucus by washing), and reacting with basic fuchsin for 1 minute. See column 10 lines 49-55. Shamsuddin1994 teaches a capped vial containing storage-stable basic fuchsin. See column 9 lines 56-57.
Shamsuddin1994 does not teach activating a container with Schiff reagent solution.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to react the washed membrane with the Schiff reagent solution, as taught by Shamsuddin1994, and in the process activate a container with the Schiff reagent solution. One of ordinary skill in the art would have been motivated to do so because Shamsuddin1994 suggests that the Schiff reagent solution is in a container prior to being used in the reaction with the washed membrane. There would have been a reasonable expectation of success because Shamsuddin1994 demonstrates reacting a washed membrane with Schiff reagent solution.
Regarding claim 16, Shamsuddin1994 teaches smearing mucus on a membrane filter, reacting with galactose oxidase, washing, and reacting with basic fuchsin for 1 minute, which is a period of 0.5 to 5 minutes as instantly required. See column 10 lines 49-55
Regarding claim 17, Shamsuddin1994 teaches placing the membrane in Schiff’s reagent for 1 minute and then washing the membrane in running tap water. Shamsuddin1994 teaches shaking off excess water and drying. A bright magenta coloration of the mucus smear indicates a positive test. See column 9 lines 16-21.
Regarding claims 18-19, Shamsuddin1994 teaches a kit that comprises separate containers of galactose oxidase, storage stable basic fuchsin (i.e. Schiff reagent solution). The galactose oxidase is impregnated into the same membrane filter onto which the mucus sample is applied. See column 7 lines 24-31.
Regarding claim 22, Shamsuddin1994 teaches testing for cancerous and precancerous condition. See column 3 lines 18-20.
Regarding claim 23, Shamsuddin1994 teaches a diagnostic tool for the detection of caners including rectal, colon, blood, lymph node, stomach, kidney, gall bladder, prostate, testes, breast, cervix and ovaries. See column 4 lines 45-52.
Regarding claim 24, Shamsuddin1994 teaches a screening test method and kit for cancerous and precancerous conditions. See the abstract. Shamsuddin1994 teaches a kit for conducting the screening test. See column 2 lines 67-68.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3, 5-10, 13-20, and 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 14-16, 20, 23 and 24 of copending Application No. 17/314,502 in view of Shamsuddin1994 (US 5,348,860).
Copending claim 1 recites a screening method for testing a subject for lung cancer, wherein the subject is asymptomatic for lung cancer, the method comprising the steps of (a) obtaining a biological sample from an individual; (b) adsorbing the biological sample onto a protein-capturing water-insoluble substrate, wherein the substrate is a test strip or membrane pre-embedded with microencapsules containing galactose oxidase, and then washing the substrate to remove non-immobilized components of the biological sample from the substrate, and assaying a portion of the biological sample for the presence therein of glycoprotein containing at least one carbohydrate selected from the group consisting of beta-D-Gal-(1->3)-D-GalNAc, Fuc-alpha-1->2 Gal-Beta(1->4)-Fuc-alpha- 1->3-GlcNAc, Fuc-Alpha-1->2 Gal-beta-(1->4)-Fuc-alpha-1->3-GlcNAc-beta-(1->3)- Gal-beta-(1>4)-GlcNAc and Fuc-alpha-1->2-Gal-beta-(1->4)-Fuc-alpha-1->3-GlcNAc- beta-(1->3)-Gal-beta-(1->4)-Fuc-alpha-1->3-GlcNAc, by subjecting the biological sample to oxidizing conditions by activating the pre-embedded galactose oxidase with water such that the primary hydroxy groups of any galactose moieties of the glycoprotein in the biological sample are oxidized to aldehydic groups and then visualizing any aldehydic saccharide groups thus formed with a Schiff’s base dye; (c) also assaying a portion of the biological sample for the presence therein of any glycoprotein by subjecting the biological sample to the oxidizing action of an oxidizing agent which oxidizes the saccharide moieties of any glycoprotein therein to aldehydic sugar moieties and then visualizing any thus-produced aldehydic sugar moieties, the presence of thereby formed aldehydic sugar moieties confirming the adequacy of the sampling and the absence therein of thereby formed aldehyde sugar moieties establishing that negative test results were due to sampling error; (d) retesting the individual in the same manner with a fresh biological sample, if the first assays are negative in steps (b) and (c); (e) diagnosing the asymptomatic patient as having cancer or a precancerous condition based on visualizing a color change in the Schiff's base dye and (f) upon positive diagnosis in step (e), beginning treatment for lung cancer or reinstating a previously suspended treatment for.
Copending claim 8 recites a method according to claim 1, wherein step (c) is conducted concurrently with step (b) on a different portion of the same biological sample; and wherein immediately thereafter, when a negative result is obtained in both of steps (b) and (c), another sample of biological sample is collected from the individual and steps (a), (b) and (c) are repeated.
Copending claim 14 recites a method for screening for lung cancer in a human being, wherein the human being is asymptomatic for lung cancer, the method comprising the steps of (a) obtaining a sample of proteinaceous secretion or proteinaceous fluid other than rectal mucus associated with that organ from an individual; (b) adsorbing the sample onto a protein-capturing water-insoluble substrate, wherein the substrate is a test strip or membrane pre-embedded with microencapsules containing galactose oxidase, and then washing the substrate to remove non-immobilized components of the sample from the substrate, and (c) subjecting the sample of proteinaceous secretion or proteinaceous fluid other than rectal mucus associated with that organ, to an assay for the presence therein of a marker carbohydrate selected from the group consisting of beta-D-Gal-(1->3)-D-GalNAc, Fuc- alpha-1->2 Gal-Beta(1->4)-Fuc-alpha-1->3-GlcNAc, Fuc-Alpha-1->2 Gal-beta-(1->4)-Fuc- alpha-1->3-GlcNAc-beta-(1->3)-Gal-beta-(1>4)-GlcNAc and Fuc-alpha-1->2-Gal-beta-(1- >4)-Fuc-alpha-1->3-GlcNAc-beta-(1->3)-Gal-beta-(1->4)-Fuc-alpha-1->3-GlcNAc, by selectively oxidizing any glycoprotein in the sample by activating the pre-embedded galactose oxidase with water so as to selectively oxidize the primary hydroxy group of any galactose sugar moiety of any said marker carbohydrate therein to an aldehydic group and the thus-oxidized galactose moiety is visualized with a Schiff's base dye.
Copending claim 15 recites a method according to claim 14, wherein a portion of the sample which tests negative in that assay is further oxidized with periodic acid and the aldehydic sugar moiety in the thus-oxidized sample is visualized.
Copending claim 16 recites a method according to claim 15, which comprises the portion of the sample of proteinaceous secretion which is oxidized with periodic acid is a different portion of the same sample which is oxidized with galactose oxidase and is oxidized concurrently therewith.
Copending claim 23 recites the method of claim 1, wherein the microencapsules containing galactose oxidase are formed of a polymer capable of providing a controlled release of the galactose oxidase.
Copending claim 24 recites the method of claim 14wherein the microencapsules containing galactose oxidase are formed of a polymer capable of providing a controlled release of the galactose oxidase.
The copending claims lack: a container with Schiff reagent solution, wherein the Schiff reagent solution is not initially in contact with the test strip or membrane, and the Schiff reagent solution can be activated to contact the test strip or membrane after marker carbohydrates are oxidized by galactose oxidase (relevant to instant claims 1-2 and 18-19); wherein the Schiff reagent solution is activated by opening a twist valve or by breaking a barrier between the Schiff reagent solution container and the test strip or membrane (relevant to instant claim 5); wherein the Schiff reagent solution is a storage-stable Schiff reagent solution (relevant to instant claim 6); wherein the cancerous condition is rectal, colon, blood, lymph node, stomach, kidney, gall bladder, prostate, testes, breast, cervix or ovaries (relevant to instant claim 23).
However, Shamsuddin1994 teaches a kit that comprises separate containers of galactose oxidase, storage stable basic fuchsin. See column 7 lines 24-31 (relevant to instant claims 1-2, 6 and 18-19). Shamsuddin1994 teaches a capped vial containing an amount of storage-stable basic fuchsin. See column 9 lines 55-56 (relevant to instant claim 5). Shamsuddin1994 teaches a diagnostic tool for the detection of caners including rectal, colon, blood, lymph node, stomach, kidney, gall bladder, prostate, testes, breast, cervix and ovaries. See column 4 lines 45-52 (relevant to instant claim 23).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to combine the test strip or membrane pre-embedded with microencapsules containing galactose oxidase recited in copending claims 1 and 14 with Shamsuddin1994’s kit comprising a container of storage-stable Schiff reagent solution in order to screen a human being for expression of a mucosal carbohydrate, or for a cancerous or precancerous condition.
The copending claims lack: a method comprising activating a container with Schiff reagent solution adjacent to the test strip or membrane to contact the test strip or membrane (relevant to instant claims 7-8); wherein the Schiff reagent solution is activated by opening a twist valve or by breaking a barrier between the Schiff reagent solution container and the test strip or membrane (relevant to instant claim 13); wherein oxidizing marker carbohydrates in the mucus or body fluid by reacting with galactose oxidase for a period of 5 to 20 minutes (relevant to instant claim 14); further comprising letting the Schiff reagent solution to contact the test strip or membrane for a period of 0.5 to 5 mins (relevant to instant claim 16); and further comprising washing the test strip or membrane with tap water after letting the Schiff reagent solution to contact the test strip or membrane for a period of 0.5 to 5 mins, drying the test strip or membrane, and evaluating color of the test strip or membrane (relevant to instant claim 17).
However, Shamsuddin1994 teaches a container of basic fuchsin. See column 7 lines 24-31 (relevant to instant claims 7-8). Shamsuddin1994 teaches a capped vial containing an amount of storage-stable basic fuchsin. See column 9 lines 55-56 (relevant to instant claim 13). Shamsuddin1994 teaches smearing mucus on a membrane filter, reacting with galactose oxidase for 10 minutes, washing with deionized distilled water, and reacting with basic fuchsin for 1 minute. See column 10 lines 49-55 (relevant to instant claims 14 and 16). Shamsuddin1994 teaches placing the membrane in Schiff’s reagent for 1 minute, then washing the membrane in running tap water, drying and a bright magenta coloration. See column 9 lines 16-21 (relevant to instant claim 17).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to substitute the Schiff’s base dye and water recited in copending claims 1 and 14 with Shamsuddin1994’s container with Schiff reagent solution and tap water respectively, and to further optimize the timing of the steps in order to screen a human being for expression of a mucosal carbohydrate, or for a cancerous or precancerous condition.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 5-10, 13-20, and 22-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over patent claims 1-16 of U.S. Patent No. 4,857,457 (as cited in the IDS filed 10/21/2024) in view of Shamsuddin1988 (WO 88/00702), and Shamsuddin1994 (US 5,348,860).
Patent claim 1 recites a method for detecting the presence of precancer or cancer of the large intestine [i.e. stomach], which comprises:
(a) obtaining a sample of large intestinal mucus from the rectum of a patient;
(b) assaying said sample to detect the disaccharide marker beta-D-Gal(1->3)-D-GalNAc therein; and
(c) diagnosing precancer or cancer of the large intestine based upon the presence of the disaccharide detected in the mucus.
Patent claim 12 recites a process according to claim 1 wherein the mucus is absorbed onto a water-insoluble substrate.
Patent claim 13 recites a process according to claim 12, wherein the water-insoluble substrate is a protein-capturing membrane filter.
Patent claim 15 recites a diagnostic kit for detecting the presence of precancer or cancer of the large intestine according to the process of claim 1, which comprises a container comprising separately package galactose oxidase, a water-insoluble support capable of absorbing said large intestinal mucus, and basic fuchsin.
Patent claim 16 recites a diagnostic kit according to claim 15, wherein the basic fuchsin is package as Schiff's reagent.
The patent claims lack: a test strip or membrane with galactose oxidase pre-embedded (relevant to instant claims 1-2 and 18-19); wherein the galactose oxidase is microencapsulated (relevant to instant claims 3 and 20); wherein the Schiff reagent solution is activated by opening a twist valve or by breaking a barrier between the Schiff reagent solution container and the test strip or membrane (relevant to instant claim 5); wherein the Schiff reagent solution is a storage-stable Schiff reagent solution (relevant to instant claim 6).
However Shamsuddin1988 teaches galactose oxidase impregnated test strip. See p. 17 lines 13-15 (relevant to instant claims 1-2 and 18-19). Shamsuddin1988 teaches galactose oxidase microencapsulated. See p. 24 amended claim 20 of Shamsuddin1988 (relevant to instant claims 3 and 20). Shamsuddin1994 teaches a capped vial containing an amount of storage-stable basic fuchsin. See column 9 lines 55-56 (relevant to instant claims 5-6).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to substitute Shamsuddin1988’s test strip with pre-embedded galactose oxidase for the galactose oxidase and water-insoluble support recited in patent claim 15 and to further substitute Shamsuddin1994’s capped vial containing storage-stable basic fuchsin for the basic fuchsin recited in patent claim 15 in order to screen a human being for expression of a mucosal carbohydrate, or for a cancerous or precancerous condition.
The patent claims lack: a method comprising applying mucus or body fluid to a test strip or membrane with galactose oxidase pre-embedded, and activating a container with Schiff reagent solution adjacent to the test strip or membrane to contact the test strip or membrane (relevant to instant claims 7-8); further comprising applying water onto the test strip or membrane before applying mucus or body fluid to the test strip or membrane (relevant to instant claim 9); wherein the galactose oxidase is microencapsulated (relevant to instant claim 10); wherein activating the container with Schiff reagent solution adjacent to the test strip or membrane through opening a twist valve or breaking a barrier between the Schiff reagent solution container and the test strip or membrane (relevant to instant claims 13); wherein oxidizing marker carbohydrates in the mucus or body fluid by reacting with galactose oxidase for a period of 5 to 20 minutes (relevant to instant claim 14); further comprising removing the mucus or body fluid by washing before activating a container with Schiff reagent solution (relevant to instant claim 15); further comprising letting the Schiff reagent solution contact the test strip or membrane for a period of 0.5 to 5 mins (relevant to instant claim 16); further comprising washing the test strip or membrane with tap water after letting the Schiff reagent solution to contact the test strip or membrane for a period of 0.5 to 5 mins, drying the test strip or membrane and evaluating color of the test strip or membrane (relevant to instant claim 17).
Shamsuddin1994 teaches smearing mucus on a membrane filter, reacting with galactose oxidase for 10 minutes, washing with deionized distilled water, and reacting with basic fuchsin for 1 minute. See column 10 lines 49-55. Shamsuddin1994 teaches galactose oxidase impregnated the membrane filter. See column 7 lines 29-30. Shamsuddin1994 teaches a capped vial containing an amount of storage-stable basic fuchsin. See column 9 lines 55-56 (relevant to instant claims 7-8, 13, 14-15, and 16). Shamsuddin1988 teaches saturating the impregnated test strip with deionized distilled water just before the test. See p. 17 lines 15-16 (relevant to instant claim 9). Shamsuddin1988 teaches galactose oxidase impregnated test strip. See p. 17 lines 13-15 (relevant to instant claims 1-2 and 18-19). Shamsuddin1988 teaches galactose oxidase microencapsulated. See p. 24 amended claim 20 of Shamsuddin1988 (relevant to instant claim 10). Shamsuddin1994 teaches placing the membrane in Schiff’s reagent for 1 minute, then washing the membrane in running tap water, drying and a bright magenta coloration. See column 9 lines 16-21 (relevant to instant claim 17).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to substitute Shamsuddin1994’s galactose oxidase pre-embedded membrane for the membrane filter recited in patent claim 13, and to further apply Shamsuddin1994’s tap water and Schiff reagent solution in order to screen a human being for expression of a mucosal carbohydrate, or for a cancerous or precancerous condition.
Claims 1-3, 5-10, 13-20, and 22-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over patent claims 1-25 of U.S. Patent No. 5,348,860 (as cited in the IDS filed 10/21/2024) in view of Shamsuddin1988 (WO 88/00702), and Shamsuddin1994 (US 5,348,860).
Patent claim 1 recites a screening method for rapidly testing a human being for a cancerous or precancerous condition and as part of the same testing eliminating the possibility of a false negative, whereby the individual can be immediately retested if a negative assay is due to procedural error, which comprises the steps of (a) obtaining a sample of rectal mucus from an individual; (b) assaying a portion of the sample for the presence therein of glycoprotein containing at least one carbohydrate selected from the group consisting of beta-D-Gal-(1->3)-D-GalNAc, Fuc-alpha-1->2 Gal-Beta(1->4)-Fuc-alpha-1->3-GlcNAc, Fuc-Alpha-1->2 Gal-beta-(1->4)-Fuc-alpha-1->3-GlcNAcbeta-(1->3)-Gal-beta-(1>4)-GlcNAc and Fuc-alpha-1->2-Gal-beta-(1->4)-Fuc-alpha-1->3-GlcNAc-beta-(1->3)-Gal-beta-(1->4)-Fuc-alpha-1->3-GlcNAc, by briefly subjecting the sample to oxidizing conditions which are capable of selectively oxidizing only the cyclic sugar moieties of any said marker carbohydrate present in the glycoprotein in the sample at a hydroxy group-bearing ring carbon atom thereof to form an aldehydic sugar moiety and then visualizing any aldehydic saccharide groups thus formed with a Schiff's base decolorized dye; (c) also assaying a portion of the sample for the presence therein of any glycoprotein by subjecting the sample to the oxidizing action of an oxidizing agent which oxidizes the saccharide moieties of any glycoprotein therein to aldehydic sugar moieties and then visualizing any thus-produced aldehydic sugar moieties, the presence of thereby formed aldehydic sugar moieties confirming the adequacy of the mucus sampling and the absence therein of thereby formed aldehyde sugar moieties establishing that the negative test results were due to mucus sampling error; and (d) either retesting the individual in the same manner with a fresh sample of rectal mucus, if the first sample assays negative in steps (b) and (c), or examining another proteinaceous fluid associated with another organ of the individual in the same manner, if the rectal mucus sample tests positive and no abnormality of the rectum or colon is found.
Patent claim 2 recites a method according to claim 1, wherein the assay comprises the steps of adsorbing the mucus sample onto a protein-capturing water-insoluble substrate and then washing the substrate to remove non-immobilized components of the mucus sample from the substrate.
Patent claim 3 recites a method according to claim 2, wherein the insoluble substrate is a membrane filter.
Patent claim 4 recites a method according to claim 1, wherein the marker carbohydrate sugar moieties are assayed by selectively oxidizing the glycoprotein so as to selectively oxidize the primary hydroxy groups of any galactose moieties thereof to aldehydic groups and the thus-oxidized glycoprotein is then assayed for oxidized vicinal galactose moieties.
Patent claim 5 recites a method according to claim 4, wherein the galactose moieties are oxidized with galactose oxidase.
Patent claim 6 recites a method according to claim 4, performed simultaneously on a plurality of samples obtained from a plurality of individuals rectal mucus as part of a field screening for cancer.
Patent claim 7 recites a method according to claim 5, wherein the oxidized vicinal galactose moieties are visualized with basic fuchsin.
Patent claim 8 recites a method according to claim 1, wherein step (c) is conducted concurrently with step (b) on a different portion of the same mucus sample; and wherein immediately thereafter, when a negative result is obtained in both of steps (b) and (c), immediately thereafter another sample of rectal mucus is collected from the individual steps (a), (b) and (c) are repeated.
Patent claim 9 recites a method according to claim 8, wherein any aldehydic sugar moieties in a mucus sample further oxidized with periodic acid are visualized with basic fuchsin.
Patent claim 10 recites a method according to claim 1, wherein prior to the assaying thereof the rectal mucus sample is adsorbed onto a protein-capturing water-insoluble substrate and the substrate is then washed to remove the non-immobilized components of the mucus sample from the substrate; wherein the sample is assayed in step (a) by selectively oxidizing any glycoprotein in the sample so as to oxidize the primary hydroxy group of the galactose sugar moiety of any said carbohydrate therein to an aldehydic group and the thus-oxidized galactose moiety is then visualized with basic fuchsin; and wherein a mucus sample which tests negative in that assay is further oxidized with periodic acid and the aldehydic sugar moiety in the thus-oxidized sample is visualized with basic fuchsin.
Patent claim 11 recites a method according to claim 10, wherein the insoluble substrate is a membrane filter and wherein the galactose sugar moieties are oxidized with galactose oxidase.
Patent claim 12 recites a method according to claim 10, wherein the oxidizing agent for the galactose moieties is present in the insoluble substrate or is applied directly thereto after the mucus sample is applied thereto.
Patent claim 13 recites a method according to claim 12, wherein the insoluble substrate is a membrane filter, wherein the galactose sugar moieties are oxidized with galactose oxidase and wherein the galactose oxidase is applied directly to the membrane filter after the mucus sample is applied thereto.
Patent claim 14 recites a method of eliminating a false negative as a result of mucus sampling error in a rectal mucus method for screening for a cancerous or precancerous condition in a human being, which comprises conducting, within about a half hour period after collecting a sample of rectal mucus, the steps of (a) subjecting a first portion of the sample of rectal mucus in an assay for the presence therein of at least one marker carbohydrate selected from the group consisting of beta-D-Gal-(1->3)-D-GalNAc, Fuc-alpha-1->2 Gal-Beta(1->4)-Fuc-alpha-1->3-GlcNAc, Fuc-Alpha-1->2Gal-beta-(1->4)-Fuc-alpha-1->3-GlcNAc-beta-(1->3)-Gal-beta-(1>4)-GlcNAc and Fuc-alpha-1->2-Gal-beta-(1->4)-Fuc-alpha-1->3-GlcNA-beta-(1->3)-Gal-beta-(1->4)-Fuc-alpha-1->3-GlcNAc, and (b) either concurrently subjecting another portion of the same mucus sample or, if the first portion tests negative in step (a), thereafter subjecting the same portion, to oxidizing conditions which are capable of oxidative ring opening of the cyclic sugar moieties of any glycoprotein present in the sample at a hydroxy group-bearing ring carbon atom thereof to form aldehydic sugar moieties and then assaying the thus-oxidized sample for the presence therein of any aldehydic sugar moieties thus formed, the presence of thereby formed aldehydic sugar moieties confirming the adequacy of the mucus sampling and additionally, when the assay for marker carbohydrates is negative, that none of the marker carbohydrates are present in the mucus sample.
Patent claim 15 recites a method according to claim 14, wherein prior to the assaying thereof the rectal mucus sample is adsorbed onto a protein-capturing water-insoluble substrate and the substrate is then washed to remove the non-immobilized components of the mucus sample from the substrate; wherein a first portion of the sample is assayed for the marker carbohydrates by selectively oxidizing any glycoprotein in the sample with galactose oxidase so as to selectively oxidize the primary hydroxy groups of any galactose sugar moieties thereof to aldehydic sugar moieties; the thus-oxidized is then assayed for oxidized vicinal galactose moieties; and wherein a separate second portion of the rectal sample is concurrently oxidized in Step (b) with periodic acid and any of the cyclic sugar moieties in the thus-oxidized second portion of the sample are visualized with basic fuchsin.
Patent claim 16 recites a process for producing an aqueous solution of basic fuchsin wherein a basic solution of fuchsin and sodium bisulfate is treated with activated charcoal and is stored at below room temperature, the improvement which comprises storing the basic solution at below room temperature until the color thereof fades to a straw color before the activated charcoal is added thereto, thereby rendering the solution storage-stable and enhancing its color development ability.
Patent claim 17 recites the process according to claim 16, wherein the solution is stored at about 0°-15° C. for at least one day.
Patent claim 18 recites the process according to claim 16, wherein the basic fuchsin solution is Schiff's Reagent.
The patent claims lack: a test strip or membrane with galactose oxidase pre-embedded (relevant to instant claims 1-2 and 18-19); wherein the galactose oxidase is microencapsulated (relevant to instant claims 3 and 20); wherein the Schiff reagent solution is activated by opening a twist valve or by breaking a barrier between the Schiff reagent solution container and the test strip or membrane (relevant to instant claim 5); wherein the Schiff reagent solution is a storage-stable Schiff reagent solution (relevant to instant claim 6).
However Shamsuddin1988 teaches galactose oxidase impregnated test strip. See p. 17 lines 13-15 (relevant to instant claims 1-2 and 18-19). Shamsuddin1988 teaches galactose oxidase microencapsulated. See p. 24 amended claim 20 of Shamsuddin1988 (relevant to instant claims 3 and 20). Shamsuddin1994 teaches a capped vial containing an amount of storage-stable basic fuchsin. See column 9 lines 55-56 (relevant to instant claims 5-6).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to substitute Shamsuddin1988’s test strip with pre-embedded galactose oxidase for the water-insoluble support recited in patent claim 3 in order to screen a human being for expression of a mucosal carbohydrate, or for a cancerous or precancerous condition.
The patent claims lack: a method comprising applying mucus or body fluid to a test strip or membrane with galactose oxidase pre-embedded, and activating a container with Schiff reagent solution adjacent to the test strip or membrane to contact the test strip or membrane (relevant to instant claims 7-8); wherein the galactose oxidase is microencapsulated (relevant to instant claim 10); wherein activating the container with Schiff reagent solution adjacent to the test strip or membrane through opening a twist valve or breaking a barrier between the Schiff reagent solution container and the test strip or membrane (relevant to instant claims 13); wherein oxidizing marker carbohydrates in the mucus or body fluid by reacting with galactose oxidase for a period of 5 to 20 minutes (relevant to instant claim 14); further comprising removing the mucus or body fluid by washing before activating a container with Schiff reagent solution (relevant to instant claim 15); further comprising letting the Schiff reagent solution contact the test strip or membrane for a period of 0.5 to 5 mins (relevant to instant claim 16); further comprising washing the test strip or membrane with tap water after letting the Schiff reagent solution to contact the test strip or membrane for a period of 0.5 to 5 mins, drying the test strip or membrane and evaluating color of the test strip or membrane (relevant to instant claim 17).
Shamsuddin1994 teaches smearing mucus on a membrane filter, reacting with galactose oxidase for 10 minutes, washing with deionized distilled water, and reacting with basic fuchsin for 1 minute. See column 10 lines 49-55. Shamsuddin1994 teaches galactose oxidase impregnated the membrane filter. See column 7 lines 29-30. Shamsuddin1994 teaches a capped vial containing an amount of storage-stable basic fuchsin. See column 9 lines 55-56 (relevant to instant claims 7-8, 13, 14-15, and 16). Shamsuddin1988 teaches galactose oxidase microencapsulated. See p. 24 amended claim 20 of Shamsuddin1988 (relevant to instant claim 10). Shamsuddin1994 teaches placing the membrane in Schiff’s reagent for 1 minute, then washing the membrane in running tap water, drying and a bright magenta coloration. See column 9 lines 16-21 (relevant to instant claim 17).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to substitute Shamsuddin1994’s galactose oxidase pre-embedded membrane for the water-insoluble support recited in patent claim 3, and to further apply the tap water and Schiff reagent solution of Shamsuddin1994 in order to screen a human being for expression of a mucosal carbohydrate, or for a cancerous or precancerous condition.
Claims 1-3, 5-6, 18-20, and 22-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 5,162,202 (as cited in the IDS filed 10/21/2024) in view of Shamsuddin1988 (WO 88/00702), Shamsuddin1994 (US 5,348,860).
Patent claim 1 recites a diagnostic kit for detecting a cancerous condition in human beings and for determining sample sufficiency which comprises galactose oxidase; a water-insoluble support capable of absorbing rectal mucus; periodic acid; and a solution of basic fuchsin which is storage stable for at least one year and which is produced by storing a basic solution of fuchsin and sodium bisulfite at below room temperature until the color thereof fades to straw color and then treating the resulting solution with activated charcoal.
Patent claim 2 recites diagnostic kit according to claim 1, wherein the basic fuchsin is a Schiff's Reagent and the water-insoluble support is a membrane filter.
The patent claims lack: a test strip or membrane with galactose oxidase pre-embedded (relevant to instant claims 1-2 and 18-19); wherein the galactose oxidase is microencapsulated (relevant to instant claims 3 and 20); wherein the Schiff reagent solution is activated by opening a twist valve or by breaking a barrier between the Schiff reagent solution container and the test strip or membrane (relevant to instant claim 5); wherein the Schiff reagent solution is a storage-stable Schiff reagent solution (relevant to instant claim 6).
However Shamsuddin1988 teaches galactose oxidase impregnated test strip. See p. 17 lines 13-15 (relevant to instant claims 1-2 and 18-19). Shamsuddin1988 teaches galactose oxidase microencapsulated. See p. 24 amended claim 20 of Shamsuddin1988 (relevant to instant claims 3 and 20). Shamsuddin1994 teaches a capped vial containing an amount of storage-stable basic fuchsin. See column 9 lines 55-56 (relevant to instant claims 5-6).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to substitute Shamsuddin1988’s test strip with pre-embedded and microencapsulated galactose oxidase for the galactose oxidase and water-insoluble support recited in patent claim 1 in order to screen a human being for expression of a mucosal carbohydrate, or for a cancerous or precancerous condition.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY C BREEN whose telephone number is (571)272-0980. The examiner can normally be reached M-Th 7:30-4:30, F 8:30-1:30 (EDT/EST).
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/K.C.B./Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
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