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
Applicant’s submission filed on 10/11/2024 is duly acknowledged.
Claims 1-17 as currently presented are pending in this application and have been examined on their merits in this action hereinafter.
Priority
This application is a DIV of 16/936,998 (filed on 07/23/2020, now ABN), which claims domestic benefit from a US provisional application 62/893,477 filed on 08/29/2019.
Duplicate Claims Warning
A. Applicant is advised that should claim 1 be found allowable, claim 2 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 1 and 2 are identical to each other except for the preambles that recite different intended uses. MPEP 2111.02 indicates that claim preambles carry no patentable weight when they do not limit the scope of the claim. The parent specification 16/936,998 points to testing for mucosal carbohydrates when testing for cancerous or precancerous conditions (see 16/936,998 SPEC, paragraphs [0009]-[0014], [0027], [0036], [0042], [0069]-[0070], and [0076]). There is no suggestion from the disclosure, and especially the active method steps as recited, that testing for a cancerous or precancerous condition is any different from testing for a mucosal carbohydrate as they are merely intended uses and the steps of the processes remain the same. Therefore, claims 1 and 2 are deemed substantial duplicates of each other and are subject to objection if any one of these claims is found to be allowable during prosecution.
B. Claims 3 and 10 as presented, each directly depend from independent claim 1, and are duplicate of each other, and are subject to objection if any one of these claims is found to be allowable during prosecution. Appropriate correction is required.
Claim Objections
1. Claims 6 and 13 (as recited) are objected to because of the following informalities: Claim 6 (depends from claim 1) recites the limitations “wherein oxidizing marker carbohydrates in the mucus or body fluid by reacting with galactose oxidase for a period of 5 to 20 minutes”, which should be amended to recite “wherein the step of oxidizing marker carbohydrates in the mucus or body fluid is performed by reacting with galactose oxidase for a period of 5 to 20 minutes” in order to clarify the process as claimed.
Similar situation arises with the recitation of instant claim 13 (that depends from claim 2) as discussed above, that should be amended appropriately as discussed for claim 6. Appropriate correction is required.
2. Claims 8 and 15 (as recited) are objected to because of the following informalities: Claim 8 (directly depends from claim 1) recites the limitations “further comprising letting the Schiff reagent to contact the sample for a period of 0.5 to 5 mins”, which should be amended to recite “further comprising letting the Schiff reagent to contact the oxidized sample for a period of 0.5 to 5 mins” in order to clarify the process as claimed.
Similar situation arises with the recitation of instant claim 15 (that depends from claim 2) as discussed above, and should be amended appropriately as discussed for claim 8. 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.
1. Claims 1-17 (as presented) 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.
Claims 1 and 2 as currently presented recite the limitation of the term "rapidly" in the preamble, which is a relative term which renders the claimed processes indefinite. The term "rapidly" is not defined by the claims, the parent specification (16/936,998 of record) does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The parameter of the rate at which screening or testing occurs, or is completed is rendered indefinite by the term "rapidly". Because the term is not specifically defined by the claim(s) or the specification of record (see parent SPEC, [0034]), it is unclear whether or how it limits the rate of the testing, and in turn it is unclear if the rate places any implicit limitation on the active method steps as currently recited in instant claims 1 and 2. Therefore, it is unclear what testing rate, if any, the processes must be capable of achieving in order to satisfy the claim or to avoid infringing it, and it is unclear if "rapidly" implies any limitation on the specific steps of the processes as claimed.
The dependent claims 3-17 are included in this rejection because they directly depend from claim 1, or claim 2, and do not specifically resolve the above discussed issue. Appropriate correction and/or explanation is required.
2. Claims 1 and 2, each recite the method step limitation that end with a period within the claimed process (see lines 3 of each claim that recite the step of “mixing mucus or body fluid with a galactose oxidase solution.”), which renders the claimed processes indefinite because it is not clear if the rest of the limitations that follow the aforementioned step ending in a period are in fact required, or not. Therefore, the metes and bounds of the claimed processes cannot be properly ascertained. Appropriate correction is required.
3. In addition, instant claims 5 and 12, each recite the limitations “wherein the test strip or membrane further contains dry culture medium, and the dry culture medium can activate the galactose oxidase once water is added onto the test strip or membrane”, which render the claimed processes ambiguous and confusing. Regarding claim 5, for instance, the limitation of “once water is added onto the test strip or membrane” renders the claim indefinite as it is not clear as to when or if at all the “water” is being added “onto the test strip or membrane”. The claimed process does not provide for at which step in claim 1 (from which instant claim 5 directly depends from) the “water is added onto the test strip or membrane”. Is it at the step of “applying the oxidized sample to a test strip….pre-embedded”, or before said step of applying; or at the step of “activating the Schiff reagent in the test strip or membrane to contact the oxidized sample”, or prior to said activating ? Although, instant claim 3 (depends directly from claim 1) recites the limitations “further comprising applying water onto the test strip or membrane before applying mucus or body fluid to the test strip or membrane”, it fails to provide a reasonable basis for the limitations of “dry culture medium” per se. Therefore, the process of claim 5, as currently presented fails to properly define the metes and bounds of the claimed process and is thus deemed indefinite.
Similar situation arises for instant claim 12, as currently presented, and as discussed for claim 5 above. Appropriate correction and/or explanation is required.
NOTE: 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
1. Claims 1-17 (as presented) are rejected under 35 U.S.C. 103 as being unpatentable over Shamsuddin et al (1995; NPL cited as ref. [U] on PTO 892 form) taken with BR 102012012197 A2 (2014; English translation attached as ref. [V] on PTO 892 form), Davies et al (1975; NPL cited as ref. [W] on PTO 892 form) and Angros (US 10,393,632 B2; cited as ref. [A] on PTO 892 form).
Claims 1 and 2 as presented have been reproduced hereinbelow:
“1. A screening method for rapidly testing a human being for expression of a mucosal carbohydrate comprising:
mixing mucus or body fluid with a galactose oxidase solution.
oxidizing marker carbohydrates in the mucus or body fluid by reacting with galactose oxidase to form an oxidized sample,
applying the oxidized sample to a test strip or membrane with a Schiff reagent pre-embedded,
activating the Schiff reagent in the test strip or membrane to contact the oxidized sample.”
“2. A screening method for rapidly testing a human being for a cancerous or precancerous condition comprising
mixing mucus or body fluid with a galactose oxidase solution.
oxidizing marker carbohydrates in the mucus or body fluid by reacting with galactose oxidase to form an oxidized sample,
applying the oxidized sample to a test strip or membrane with a Schiff reagent pre-embedded,
activating the Schiff reagent in the test strip or membrane to contact the oxidized sample.”
It is to be noted that the active method steps recited in instant claims 1 and 2 are the same, wherein the preamble as recited in claim 2 when taken with the body of the claim does not appear to structurally limit the process as claimed. See also limitations of dependent claims 3-17 as currently recited.
Shamsuddin et al (1995) discloses a screening test method for detecting mucosal carbohydrates including D-galactose-beta-1-3-N-acetyl-D-galactosamine as marker associated with cancer (see Abstract); wherein the method employs oxidation of said carbohydrates with a galactose oxidase enzyme solution (“Tissue sections were bathed with D- galactose oxidase (Sigma Chemical Company, St. Louis, MO; activity, 1000 units/mg protein) by overlaying the drops on slides at 5 units/ml overnight at room temperature (note that the reaction time can be shortened to 1 h when a higher concentration of the enzyme is used)”; see p. 149, right column, second paragraph); wherein the method comprises the step of contacting a Schiff's reagent with a sample after it has been oxidized by galactose oxidase ("Tissue sections were bathed with D-galactose oxidase (Sigma Chemical Company, St. Louis, MO; activity, 1000 units/mg protein) by overlaying the drops on slides at 5 units/ml overnight at room temperature (note that the reaction time can be shortened to 1 h when a higher concentration of the enzyme is used). The sections were then rinsed in distilled water for 10 min and stained with 2% Schiff's reagent (basic fuchsin) for 15 min"; see p. 149, right column, second paragraph); wherein a positive galactose oxidase-Schiff reaction imparts a magenta color which is evaluated after rinsing with tap water, dehydration and drying the slides; and wherein the method can be used for identification of such carbohydrate markers that may have great potential in mass screening for cancers (see Abstract).
However, Shamsuddin et al do not disclose the method that employs a test strip or membrane that has been pre-embedded with a microencapsulated Schiff reagent (instant claims 1-2 and claims 4 and 11); and wherein the test strip or membrane further comprises a “dry culture medium” (see instant claims 5 and 12; it is to be noted that the term “dry culture medium” has not been specifically defined and/or disclosed/exemplified by the applicants on record; see SPEC, [0013], [0039], [0041],for instance).
BR 102012012197 A2 (2014; all citations per English translation attached) discloses a strip containing stabilized Schiff's reagent (“In the Examples, the stabilized Schiff's Reagent as proposed in the present invention, such as paper strips, powders and silica gels had durability times greater than 2 months. Complementary storage procedures such as refrigeration and light protection aim to further extend the shelf life of this reagent”; see p. 9, third paragraph); and wherein adding the Schiff's reagent to a paper strip was shown to provide higher durability over time than standard Schiff's reagent. BR 102012012197 A2 discloses the benefit of immobilizing Schiff's reagent in solid matrices also includes preparing kits for the detection of aldehydes (present on mucosal carbohydrates that have been oxidized by galactose oxidase) for on-site and field analysis (see p. 9, second paragraph).
Davies et al (1975) disclose the Microstix (Ames Co.), which is a test strip that has agar medium dehydrated on it to extend shelf life (taken as “dry culture medium”; see p. 750, left column, first paragraph).
Angros (2019) discloses microencapsulating detection reagents, biological stains, and dyes (see Col. 2, lines 55-66). Schiff's reagent was known in the art to be a detection reagent, biological stain, and dye. Angros indicates that the benefit of encapsulating reagents for laboratory testing of biological specimens includes providing stability under storage and shipping conditions, as well as the decreased processing time or steps to activate or use reagents (see Col. 14, lines 47-58).
Therefore, given the detailed teachings in the cited prior art references above, it would have been obvious to an artisan of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the strip containing immobilized Schiff's reagent disclosed by BR 102012012197 A2 for the Schiff's reagent solution used by Shamsuddin et al in the method for testing mucosal carbohydrates using galactose oxidase. An artisan of ordinary skill in the art would have been motivated to modify the method so to improve the stability of the Schiff's reagent on the test strip. The Schiff's reagent strip disclosed by BR 102012012197 A2, absent any evidence to the contrary, can have oxidized tissue or mucus smeared on it for screening or testing purposes. It would have been obvious to an artisan of ordinary skill in the art before the effective filing date of the claimed invention to have combined the dehydrated agar medium on the test strip, as disclosed by Davies et al, with the strip containing Schiff's reagent as disclosed by BR 102012012197 A2. An artisan of ordinary skill in the art would have been motivated to add dry culture medium to a test strip as it would lengthen the shelf life of the culture medium which is advantageous for a screening method using a test strip that needs to be stored and available for use at any given time. Furthermore, it would have been obvious to an artisan of ordinary skill in the art to have substituted the microencapsulated detection reagent disclosed by Angros for the Schiff reagent to be impregnated on the test strip used in BR 102012012197 A2 to arrive at the process invention as currently claimed. Since, BR 102012012197 A2 teaches impregnating Schiff reagent on solid matrices which can support the reagent on its surface (see p. 8, paragraph 11), wherein the process involves soaking the matrix in the Schiff reagent, then drying the matrix (see p. 9, last paragraph, p. 10, first passage-second paragraph), an artisan in the art would have been motivated to make this substitution in the process to provide a stabilized reagent located conveniently on a test strip ready for laboratory testing of biological specimens, such as mucosal carbohydrates, including samples of mucus from patients having or suspected of having cancers, such as colorectal neoplasms or precancers, etc. (as already eluded by Shamsuddin et al, see p. 151, right column, 3rd paragraph). Given the detailed disclosure from Shamsuddin et al when taken with BR 102012012197 A2, Davies et al and Angros as discussed above (see Shamsuddin et al, p. 149, section “Galactose Oxidase-Schiff Sequence Staining”, in particular), the limitations of washing the mucus or body fluids before activating the pre-embedded Schiff reagent (instant claims 7 and 14), in order to remove extraneous components from the oxidized sample, for instance, would have been obvious and/or fully contemplated by an artisan of ordinary skill in the art (at least to provide for clear evaluation of the color) before the effective filing date of the invention as claimed, unless evidence/data provided on record to the contrary (which is currently lacking on record; see parent SPEC, Example 1, Figure 2).
Thus, the claim as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as currently claimed.
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
Conclusion
NO claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657
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