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 amendment submitted on 12/1/2025 is acknowledged. Claims 1, 8, and 14-24 remain pending in the instant application.
Claims 1, 14 and 23-24 are currently amended. Claims 2-7 and 9-13 are canceled. Please note, the amendment does not properly notate the cancelation of claim 13.
Claims 17-19 and 21-22 remain withdrawn pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claims 1, 8, 14-16, 20, and 23-24 are the subject of this office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/1/2025 has been entered.
Priority
The instant application is a Continuation-In-Part application of U.S. Application No. 16/936,998 filed on 7/23/2020 and US Application No. 16/937,051 filed on 7/23/2020 and claims domestic benefit to U.S. Provisional Application No. 62/893,477 filed on 8/29/2019 and to U.S. Provisional Application No. 62/893,484 filed on 8/29/2019. The Provisional Applications do not provide support for amended claim 1. Thus, the earliest effective U.S. filing date afforded the instantly claimed invention has been determined to be 7/23/2020, the filing date of ‘051.
Claim Objections
Claims 1, 14, 16, 20, and 23-24 are objected to because of the following informalities:
In Claims 1, 14, and 23-24, the claim term “microencapsules” is misspelled in lines 6, 7, 1, and 1, of each respective claim and should be replaced with “microcapsules”.
Claim 1 recites multiple redundant and superfluous limitations, and has improper punctuation. The preamble recitation is convoluted. Claim 1 inconsistently recites a subject in the preamble, an individual in step (a), and a patient in step (e). The comma after “GlcNAc” in line 13 is improper. Step (b) is convoluted and should be divided. The recitation of “by subjecting the biological sample to the oxidizing action of an oxidizing agent which oxidizes” in step (c) is redundant. Step (c) is convoluted and should be divided. Claim 1 is missing a semi colon at the end of step (e). In the last line of the claim, “lung cancer” is both added and struck-through.
Claim 1 can be amended to:
A method of screening for lung cancer in an asymptomatic subject, comprising:
(a) obtaining a biological sample from the asymptomatic subject;
(b) adsorbing the biological sample onto a protein-capturing and water-insoluble substrate that is a test strip or membrane and is pre-embedded with microcapsules containing galactose oxidase;
(c) washing the substrate to remove non-immobilized components of the biological sample from the substrate;
(d) assaying a first portion of the biological sample adsorbed onto the substrate for the presence 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 activating the pre-embedded microencapsulated galactose oxidase with water, such that the primary hydroxy groups of any galactose moieties of the glycoprotein in the biological sample are selectively oxidized to aldehydic groups;
(e) contacting a Schiff’s base dye with the first portion of the biological sample prepared in step (d), whereby a color change in the Schiff’s base dye indicates aldehydic saccharide groups were formed in step (d);
(f) assaying a second portion of the biological sample adsorbed onto the substrate for the presence of any glycoprotein by contacting the second portion to periodic acid, such that saccharide moieties of any glycoprotein are oxidized to aldehydic sugar moieties,
(g) contacting a Schiff’s base dye with the second portion of the biological sample prepared in step (f), whereby a color change in the Schiff’s base dye indicates aldehydic sugar moieties were formed in step (f);
(h) repeating steps (b) through (g) with a second biological sample obtained from the asymptomatic subject if no color change is visualized in steps (e) and (g);
(i) diagnosing the asymptomatic subject as having lung cancer if color changes are visualized in steps (e) and (g), or as not having lung cancer if no color changes are visualized upon completing step (h); and
(j) upon diagnosing the asymptomatic subject as having lung cancer, beginning treatment for lung cancer.
Claim 14 recites multiple redundant and superfluous limitations, has improper punctuation, and contains extra spacing after (c) in line 9. The preamble recitation is convoluted. The recitation of “proteinaceous secretion” is superfluous since a proteinaceous fluid embraces secretions. Claim 14 inconsistently recites a human being in the preamble and an individual in step (a). The comma after “GlcNAc” in line 15 is improper. Claim 14 should be amended similarly to the suggested amendment to claim 1.
Claim 16 is a run-on sentence and convoluted.
Claim 20 is missing a comma after the recitation of “claim 14” in the preamble.
Appropriate correction is required.
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, 8, 14-16, 20, and 23-24 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.
Claim 1 recites “a subject” in the preamble, “an individual” in line 4, and “the asymptomatic patient” in line 26. It is not clear if the subject, individual, and asymptomatic patient all refer to the same limitation or to distinct limitations. Applicant should amend claim 1 to use a consistent claim term.
Claim 1 recites the narrow limitation “lung cancer” in the preamble and the broader limitation “cancer or precancerous condition” in step (e). The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim. Lung cancer represent a specific cancer species. Thus, it is not clear if lung cancer is merely exemplary of the claim , and therefore not required, or a required feature of the claims.
Claim 1 recites “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” in lines 22-24. It is not clear how the adequacy of the sampling is confirmed to establish negative test results are due to sampling error. Specifically, it is not clear how the assaying step recited in (c) confirms the adequacy of the sampling as recited.
Claim 1 recites “reinstating a previously suspended treatment for” in the last line of the claim. A specific treatment is not recited, so it is unclear what exact treatment must be reinstated to satisfy the claim limitation. Thus, the recitation in the last line of the claim is indefinite.
Claim 8 recites “[a] method according to claim 1” in the preamble. It is not clear if claim 8 intends to include all limitations of claim 1 or if it refers to an alternative and independent claim method that selectively includes only referenced steps of claim 1. Applicant should amend claim 8 to recite: “The method of claim 1” to overcome this rejection.
Claim 14 recites “a human being” in the preamble and “an individual” in line 5. It is not clear if the human being and individual are intended to refer to the same limitations or to distinct limitations. Claim 14 recites “[a] method for screening for lung cancer in a human being” in the preamble. It is not clear how the method of claim 14 screens for lung cancer in a human being because no step identifies that the patient has or doesn’t have lung cancer. The final step of claim 14 is an assay which selectively oxidizes primary hydroxy groups of galactose sugar moieties present in the proteinaceous secretion or proteinaceous fluid into an aldehydic group and visualizing the aldehydic group with a Schiff’s base dye. There is no step that relates the visualization of aldehydic groups to identifying lung cancer. Thus, claim 14 does not clearly screen for lung cancer and is indefinite. Claim 14 further recites “(a) obtaining a sample of proteinaceous secretion or proteinaceous fluid other than rectal mucus associated with that organ from an individual”. It is unclear to what “that organ” refers to and whether the phrase “associated with that organ from an individual” is the modifier for “rectal mucus”, or if it is a limitation to another particular type of proteinaceous secretion or fluid in the claim.
Claim 15 recites “[a] method according to claim 14” in the preamble. It is not clear if claim 15 intends to include all limitations of claim 14 or if it refers to an alternative and independent claim method. Applicant should amend claim 15 to recite: “The method of claim 14” to overcome this rejection.
Claim 16 recites “[a] method according to claim 15” in the preamble. It is not clear if claim 16 intends to include all limitations of claim 15 or if it refers to an alternative and independent claim method. Moreover, claim 15 is indefinite as set forth above. Applicant should amend claim 16 to recite: “The method of claim 15” to overcome this rejection.
Claims 8, 15-16, 20, and 23-24 are also rejected for being dependent on a rejected base claim and failing to remedy the issues set forth above. Thus, the metes and bounds of claims 1, 8, 14-16, 20, and 23-24 cannot be determined.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 recites “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” in lines 2-5. Claim 8 depends from claim 1, which already recites if the assays in steps (b) and (c) are negative, the individual is retested in the same manner with a fresh biological sample. Thus, the recitation in lines 2-5 of claim 8 does not further limit this recitation in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Shamsuddin1 (U.S. Patent No. 5,348,860; of record) in view of Shamsuddin2 (WO1988/00702; of record), Carte et al. (US2007/0065893), and In et al. (Lung Cancer, 2009, Vol. 64, pp.232-237).
Regarding claim 1, Shamsuddin1 teaches a method for screening for cancerous and precancerous conditions in human patients, including asymptomatic patients (see Col. 3, lines 16-45, and Col. 10, lines 24-28 and 41-45), comprising (a) obtaining a sample of rectal mucus from an individual; (b) adsorbing the rectal mucus sample onto a protein-capturing water-insoluble substrate (see Abstract, Col. 7, lines 2-4, and Claims 2 and 10), wherein the substrate is a strip membrane filter with galactose oxidase encapsulated or impregnated (see Col. 1, lines 22-29, Col. 7, lines 28-31, and Col. 9, lines 61-66), and then washing the substrate to remove non-immobilized components of the rectal mucus sample from the substrate (see Col. 1, lines 28-31, Col. 10, lines 50-55, and Claims 2 and 10), and assaying a portion of the rectal mucus sample for the presence therein of glycoprotein containing the marker carbohydrates 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 rectal mucus sample to oxidizing conditions by activating the impregnated 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 (see Col. 3, lines 16-45, Col. 6, lines 24-29, Col. 8, lines 65-68, Col. 9, lines 1-5, Col. 10, lines 50-57, and Claims 1-2 and 10); (c) also assaying a portion of the rectal mucus 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 aldehydic sugar moieties establishing that negative test results were due to sampling error (see Col. 3, lines 16-45, and Claims 1, 8, and 14); (d) retesting the individual in the same manner with a fresh rectal mucus sample, if the first assays are negative in steps (b) and (c) (see Col. 10, lines 66-68, and Claims 1 and 8); (e) diagnosing the asymptomatic patient as having cancer or a precancerous condition based on visualizing a color change in the Schiff’s base dye (see Col. 3, lines 54-68, and Col. 6, lines 42-59). The instant specification discloses that the term “pre-embedded”, as claimed, is interchangeable with “impregnated” and “embedded”, and thus Shamsuddin1 reads on wherein the substrate is a membrane with galactose oxidase pre-embedded, as claimed.
Shamsuddin1 does not teach lung cancer, the subject is asymptomatic, the galactose oxidase is microencapsulated, or “(f) upon positive diagnosis in step (e), beginning treatment for lung cancer or reinstating a previously suspended treatment” as claimed.
Shamsuddin2 teaches a screening test for colon and rectal cancer, and teaches galactose oxidase impregnated onto a filter paper (see Abstract, p.19, 1st paragraph, and Examples 1 and 3). Shamsuddin2 further teaches the galactose oxidase is microencapsulated (see claims 15 and 20).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have impregnated microencapsulated galactose oxidase, as taught by Shamsuddin2, onto the strip membrane filter with impregnated galactose oxidase, as taught by Shamsuddin1, to arrive at the claimed invention. One of ordinary skill in the art would have been modifying the strip membrane filter of Shamsuddin1 according to known teachings in the relevant field for screening for colon cancer, yielding predictable results.
Shamsuddin2 does not teach lung cancer, the subject is asymptomatic, or “(f) upon positive diagnosis in step (e), beginning treatment for lung cancer or reinstating a previously suspended treatment” as claimed.
Carte teaches galactose oxidase-Schiff’s tests are used to detect carbohydrate markers on mucin glycoproteins expressed in cancer or pre-cancerous lesions (see paragraph [0002]). Carte further teaches these markers can be found in rectal mucus for colon cancer or saliva and sputum for lung cancer (see paragraphs [0002] and [0058]-[0064]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have substituted testing for lung cancer using sputum, as taught by Carte, for testing for colon cancer using rectal mucus in the method of Shamsuddin1 in view of Shamsuddin2, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to because Carte teaches the carbohydrate markers on mucin glycoproteins expressed in cancer and detected by galactose oxidase-Schiff’s tests can be found in sputum if testing for lung cancer, yielding predictable results. One of ordinary skill in the art would have had a reasonable expectation of success since Shamsuddin1, Shamsuddin2, and Carte teach detection of cancer-associated carbohydrates by a galactose oxidase and Schiff’s dye test.
Carte does not teach the subject is asymptomatic, or “(f) upon positive diagnosis in step (e), beginning treatment for lung cancer or reinstating a previously suspended treatment” as claimed.
In teaches asymptomatic lung cancer patients demonstrated longer survival times after receiving surgery than symptomatic patients (see Abstract – Results, paragraph bridging p.233, right column, 7th paragraph,-p.235, paragraph bridging left and right columns, and Figs. 1H-I).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have screened for lung cancer by the screening method of Shamsuddin1 in view of Shamsuddin2 and Carte in asymptomatic patients and to treat the asymptomatic patient, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to because In teaches asymptomatic patients that were treated with surgery showed longer survival times than symptomatic patients. Thus, the person of ordinary skill would have been motivated to detect and treat lung cancer as soon as possible, yielding predictable results.
Regarding claim 8, Shamsuddin1 teaches subjecting a sample which tests negative in the assay, either simultaneously employing a separate portion of the rectal mucus sample to oxidizing conditions using periodic acid which are capable of oxidative ring opening of any saccharide present in the sample at a hydroxy group-bearing ring carbon atom thereof to form an aldehydic sugar moiety and retesting another biological sample collected from the individual if the test for the separate portion of the mucus sample is negative, which reads on claim 8 (see Col. 3, lines 16-45 and Claim 8). It would have been obvious to substitute sputum from an asymptomatic patient for the rectal mucus sample and test for lung cancer instead of colon cancer as set forth above, to arrive at the claimed invention.
Claims 14-16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Shamsuddin1 (U.S. Patent No. 5,348,860; of record) in view of Shamsuddin2 (WO1988/00702; of record), and Carte et al. (US2007/0065893).
Regarding claims 14 and 20, Shamsuddin1 teaches a method for screening for a cancerous or precancerous condition in an organ other than the large intestine of a human being, wherein the human being is asymptomatic for a cancerous or precancerous condition, 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 (see Col. 2, lines 24-36, Col. 3, lines 54-68, Col. 8, lines 8-14, Col. 9, lines 38-51, Col. 10, lines 24-45, Col. 11, lines 1-18, and Claims 1 and 19); (b) adsorbing the sample onto a protein-capturing water-insoluble substrate, wherein the substrate is a strip membrane filter with galactose oxidase impregnated, and then washing the substrate to remove non-immobilized components of the sample from the substrate (see Col. 1, lines 22-29, Col. 9, lines 61-66, and Claim 20), 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 the marker carbohydrates 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 impregnated galactose 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 (see Col. 3, lines 16-45 and lines 54-68, and Claims 19 and 20). The instant specification discloses that the term “pre-embedded”, as claimed, is interchangeable with “impregnated” and “embedded”, and thus Shamsuddin1 reads on wherein the substrate is a membrane with galactose oxidase pre-embedded, as claimed.
Shamsuddin1 does not teach lung cancer or the galactose oxidase is microencapsulated as claimed.
Shamsuddin2 teaches a screening test for colon and rectal cancer, and teaches galactose oxidase impregnated onto a filter paper (see Abstract, p.19, 1st paragraph, and Examples 1 and 3). Shamsuddin2 further teaches the galactose oxidase is microencapsulated (see claims 15 and 20).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have impregnated microencapsulated galactose oxidase, as taught by Shamsuddin2, onto the strip membrane filter with impregnated galactose oxidase, as taught by Shamsuddin1, to arrive at the claimed invention. One of ordinary skill in the art would have been modifying the strip membrane filter of Shamsuddin1 according to known teachings in the relevant field for screening for colon cancer, yielding predictable results.
Shamsuddin2 does not teach lung cancer.
Carte teaches galactose oxidase-Schiff’s tests are used to detect carbohydrate markers on mucin glycoproteins expressed in cancer or pre-cancerous lesions (see paragraph [0002]). Carte further teaches these markers can be found in rectal mucus for colon cancer or saliva and sputum for lung cancer, reading on claim 20 (see paragraphs [0002] and [0058]-[0064]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have substituted testing for lung cancer using sputum, as taught by Carte, for testing for colon cancer using rectal mucus in the method of Shamsuddin1 in view of Shamsuddin2, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to because Carte teaches the carbohydrate markers on mucin glycoproteins expressed in cancer and detected by galactose oxidase-Schiff’s tests can be found in sputum if testing for lung cancer, yielding predictable results. One of ordinary skill in the art would have had a reasonable expectation of success since Shamsuddin1, Shamsuddin2, and Carte teach detection of cancer-associated carbohydrates by a galactose oxidase and Schiff’s dye test.
Regarding claim 15, Shamsuddin1 teaches 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 (see Col. 3, lines 16-45 and 54-68, and Claim 20).
Regarding claim 16, Shamsuddin1 teaches 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 (see Col. 3, lines 16-45 and lines 54-68, and Claim 21).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Shamsuddin1 (U.S. Patent No. 5,348,860; of record) in view of Shamsuddin2 (WO1988/00702; of record), Carte et al. (US2007/0065893), and In et al. (Lung Cancer, 2009, Vol. 64, pp.232-237), as applied to claims 1 and 8 above, and further in view of Shukla (WO2016/199167; of record).
Shamsuddin1 in view of Shamsuddin2, Carte, and In teach the invention of claim 1 as outlined in the rejection above.
Regarding claim 23, Shamsuddin1 in view of Shamsuddin2 teach a strip membrane filter impregnated with microencapsulated galactose oxidase.
Shamsuddin1, Shamsuddin2, Carte and In do not teach wherein the microencapsules containing galactose oxidase are formed of a polymer capable of providing a controlled release of the galactose oxidase.
Shukla teaches microcapsules modified with nanomaterial for controlled release of active agents comprising a polymer shell and a core comprising active agent and said polymer shell encompassing the core (see Abstract and Claim 1). Shukla teaches the active agent may be industrial chemical reagents (see p.5, lines 27-29, and Claim 2).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have substituted the microcapsules modified with nanomaterial, as taught by Shukla, for the microencapsules, as taught by Shamsuddin1 in view of Shamsuddin2, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to control the release of the galactose oxidase from the microencapsule, which would yield predictable results. One of ordinary skill would have a reasonable expectation since galactose oxidase is a chemical reagent.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Shamsuddin1 (U.S. Patent No. 5,348,860; of record) in view of Shamsuddin2 (WO1988/00702; of record), and Carte et al. (US2007/0065893), as applied to claims 14-16 and 20 above, and further in view of Shukla (WO2016/199167; of record).
Shamsuddin1 in view of Shamsuddin2 and Carte teach the invention of claim 14 as outlined in the rejection above.
Regarding claim 24, Shamsuddin1 in view of Shamsuddin2 teach a strip membrane filter impregnated with microencapsulated galactose oxidase.
Shamsuddin1, Shamsuddin2, and Carte do not teach wherein the microencapsules containing galactose oxidase are formed of a polymer capable of providing a controlled release of the galactose oxidase.
Shukla teaches microcapsules modified with nanomaterial for controlled release of active agents comprising a polymer shell and a core comprising active agent and said polymer shell encompassing the core (see Abstract and Claim 1). Shukla teaches the active agent may be industrial chemical reagents (see p.5, lines 27-29, and Claim 2).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have substituted the microcapsules modified with nanomaterial, as taught by Shukla, for the microencapsules, as taught by Shamsuddin1 in view of Shamsuddin2, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to control the release of the galactose oxidase from the microencapsule, which would yield predictable results. One of ordinary skill would have a reasonable expectation since galactose oxidase is a chemical reagent.
Non-Statutory 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.
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Claims 1, 8, 14-16, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 19-21, and 25 of U.S. Patent No. 5,348,860 to Shamsuddin in view of U.S. Patent No. 4,857,457 to Shamsuddin2, Shamsuddin3 (WO1988/00702), Carte et al. (US2007/0065893), and In et al. (Lung Cancer, 2009, Vol. 64, pp.232-237).
Patent claim 1 of Shamsuddin ‘860 recites a screening method for rapidly testing a subject for a precancerous or cancerous condition, wherein the subject displays no obvious signs or symptoms of a cancerous or precancerous condition (reading on an asymptomatic subject), the method comprising the steps of (a) obtaining a biological sample from an individual (obtaining a sample of rectal mucus from an individual, lines 3-4); (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 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 briefly subjected 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 dye (lines 4-9); (c) also assaying a portion of the biological 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 (lines 13-16), 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 the negative test results were due to sampling error (lines 16-19); (d) retesting the individual in the same manner with a fresh biological sample (lines 19-20), if the first sample assays negative in steps (b) and (c) (lines 19-20); and (e) diagnosing the asymptomatic patient as having cancer or a precancerous condition based on visualizing a color change in the Schiff’s base dye (lines 21-22). Both instant claim 1 and Patent claim 2 of Shamsuddin ‘860 recite wherein the assay comprises the steps of adsorbing the biological sample onto a protein-capturing water-insoluble substrate and then washing the substrate to remove non-immobilized components of the sample from the substrate (adsorbing the mucus sample onto a protein-capturing water-insoluble substrate, lines (1-3) – which is a species of the instantly claimed genus). Both instant claim 1 and Patent claim 3 of Shamsuddin ‘860 recite wherein the insoluble substrate is a membrane filter (line 1).
Both instant claim 8 and Patent claim 8 of Shamsuddin ‘860 recite wherein step (c) is conducted concurrently with step (b) on a different portion of the same biological sample (line 2); and wherein immediately thereafter, when a negative result is obtained in both of steps (b) and (c), immediately thereafter another sample of biological sample is collected (lines 3-4) from the individual steps (a), (b) and (c) are repeated (lines 1-4).
Patent claim 19 of Shamsuddin ‘860 recites a method for screening for a cancerous or precancerous condition in an organ other than the large intestine of a human being, wherein the human being displays no obvious signs or symptoms of a cancerous or precancerous condition (reading on asymptomatic), the method comprising subjecting a 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 (lines 1-7).
Both instant claim 15 and Patent claim 20 of Shamsuddin ‘860 recite wherein prior thereto the proteinaceous secretion is adsorbed onto a protein-capturing water-insoluble substrate and the substrate is then washed to remove the nonimmobilized components of the sample (line 3) from the substrate; wherein 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 group of any galactose sugar moiety of any said marker carbohydrate therein to an aldehydic group and the thus-oxidized galactose moiety is then visualized with basic fuchsin; and 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 with basic fuchsin (lines 1-9).
Both instant claim 16 and Patent claim 21 of Shamsuddin ‘860 recite 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 (lines 1-3).
Both instant claim 20 and Patent claim 25 of Shamsuddin ‘860 recite wherein the sample is sputum (line 2).
The difference between the instant claims and the claims of Patent Shamsuddin ‘860 is that claims 1 and 19 of Shamsuddin ‘860 does not recite lung cancer, the subject is asymptomatic, wherein the substrate has galactose oxidase pre-embedded, activating the pre-embedded galactose oxidase with water, and upon positive diagnosis in step (e), beginning treatment for lung cancer or reinstating a previously suspended treatment.
Shamsuddin2 teaches a method for detecting the presence of precancer or cancer in the large intestine by detecting the presence of the disaccharide β-D-Gal-(1->>3)-D-GalNAc present in a rectal mucus sample obtained from an individual (see Abstract, Fig. 2, Col. 2, lines 36-45, Col. 3, lines 34-45, and Col. 4, lines 51-55). Shamsuddin2 teaches the detection of the disaccharide is preferably carried out by oxidizing the sugar moiety of the disaccharide with galactose oxidase and visualizing the oxidized sugar with basic fuchsin (see Abstract, Col. 2, line 68, Col. 3, lines 1-19). Shamsuddin2 further teaches the galactose oxidase is preferably impregnated onto a porous support and teaches saturating galactose oxidase with water before testing, reading on wherein the substrate is a membrane with galactose oxidase pre-embedded and activating the pre-embedded galactose oxidase with water (see Col. 3, lines 14-19 and Col. 7, lines 1-3).
Shamsuddin3 teaches a screening test for colon and rectal cancer, and teaches galactose oxidase impregnated onto a filter paper (see Abstract, p.19, 1st paragraph, and Examples 1 and 3). Shamsuddin3 further teaches the galactose oxidase is microencapsulated (see claims 15 and 20).
Carte teaches galactose oxidase-Schiff’s tests are used to detect carbohydrate markers on mucin glycoproteins expressed in cancer or pre-cancerous lesions (see paragraph [0002]). Carte further teaches these markers can be found in rectal mucus for colon cancer or saliva and sputum for lung cancer (see paragraphs [0002] and [0058]-[0064]).
In teaches asymptomatic lung cancer patients demonstrated longer survival times after receiving surgery than symptomatic patients (see Abstract – Results, paragraph bridging p.233, right column, 7th paragraph,-p.235, paragraph bridging left and right columns, and Figs. 1H-I).
In view of the teachings of Shamsuddin2, it would have been obvious to one of ordinary skill in the art to have impregnated the galactose oxidase recited in Shamsuddin ‘860 on the membrane filter and to saturate the galactose oxidase in water, as taught by Shamsuddin2, because one of ordinary skill in the art would recognize that Shamsuddin ‘860 and Shamsuddin2 each teach the detection of cancer or precancer by the general principles of collecting a rectal mucus sample, adsorbing the rectal mucus sample on a substrate, oxidizing sugar moieties present in the mucus sample, and visualizing the oxidized sugar moieties with basic fuchsin and would be motivated to perform the methods as preferably described. Furthermore, in view of Shamsuddin3, it would have been obvious to have microencapsulated the galactose oxidase, because one of ordinary skill in the art would recognize that Shamsuddin ‘860, Shamsuddin2, and Shamsuddin3 each teach the detection of cancer by way of galactose oxidase. In view of the teachings of Carte and In, it would have been obvious to perform the test of Shamsuddin1 in view of Shamsuddin2 and Shamsuddin3 on an asymptomatic lung cancer patient using a sputum sample and to begin treatment for lung cancer. One of ordinary skill in the art would have been motivated to because Carte teaches the carbohydrate markers on mucin glycoproteins expressed in cancer and detected by galactose oxidase-Schiff’s tests can be found in sputum if testing for lung cancer, yielding predictable results. One of ordinary skill in the art would have been motivated to because In teaches asymptomatic patients that were treated with surgery showed longer survival times than symptomatic patients.
Claims 23 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 19-21, and 25 of U.S. Patent No. 5,348,860 to Shamsuddin in view of U.S. Patent No. 4,857,457 to Shamsuddin2, Shamsuddin3 (WO1988/00702), Carte et al. (US2007/0065893), and In et al. (Lung Cancer, 2009, Vol. 64, pp.232-237) and further in view of Shukla (WO2016/199167).
The difference between instant claims 23 and 24 and the claims of Patent Shamsuddin ‘860 in view of Shamsuddin2, Shamsuddin3, Carte and In is that the claims do not recite wherein the microencapsules containing galactose oxidase are formed of a polymer capable of providing a controlled release of the galactose oxidase.
Shukla teaches microcapsules modified with nanomaterial for controlled release of active agents comprising a polymer shell and a core comprising active agent and said polymer shell encompassing the core (see Abstract and Claim 1). Shukla teaches the active agent may be industrial chemical reagents (see p.5, lines 27-29, and Claim 2).
In view of the teachings of Shukla, it would have been obvious to microencapsulate galactose oxidase using the microcapsules of Shukla in order to control the release of galactose oxidase.
Response to Arguments
Applicant's arguments filed 12/1/2025 have been fully considered but they are not persuasive.
In Applicant’s Remarks, see p.11, 2nd paragraph,-p.12, 2nd paragraph, Applicant argues that the methods described in Shamsuddin do not teach or suggest the use of the Shamsuddin test for asymptomatic patients. Applicant further argues that nothing in Shamsuddin teaches or suggests that the test can be performed for lung cancer and is only used with rectal mucus for diagnosis of colorectal cancer. Applicant further argues nothing in Shamsuddin teaches or suggests that the test described therein can be used on sputum for screening of asymptomatic lung cancer. Applicant further argues that nothing in the cited art would lead one of ordinary skill in the art to believe that the method of Shamsuddin could be efficiently used for an asymptomatic patient for lung cancer. This is not found persuasive.
The rejection set forth above does not rely on Shamsuddin to teach screening for lung cancer in an asymptomatic subject using the test of Shamsuddin. Carte is relied upon to demonstrate that the screening method taught by Shamsuddin can be used to detect lung cancer using sputum samples. Shamsuddin teaches a method of detecting colorectal cancer by using rectal mucus samples in a galactose oxidase-Schiff’s reagent assay. Carte specifically teaches galactose oxidase-Schiff’s tests are used to detect carbohydrate markers on mucin glycoproteins expressed in cancer or pre-cancerous lesions (see paragraph [0002]). Carte further teaches these markers can be found in rectal mucus for colon cancer or saliva and sputum for lung cancer, reading on claim 20 (see paragraphs [0002] and [0058]-[0064]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have substituted testing for lung cancer using sputum, as taught by Carte, for testing for colon cancer using rectal mucus in the method of Shamsuddin1 in view of Shamsuddin2, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to because Carte teaches the carbohydrate markers on mucin glycoproteins expressed in cancer and detected by galactose oxidase-Schiff’s tests can be found in sputum if testing for lung cancer, yielding predictable results. One of ordinary skill in the art would have had a reasonable expectation of success since Shamsuddin1, Shamsuddin2, and Carte teach detection of cancer-associated carbohydrates by a galactose oxidase and Schiff’s dye test. In teaches asymptomatic lung cancer patients demonstrated longer survival times after receiving surgery than symptomatic patients (see Abstract – Results, paragraph bridging p.233, right column, 7th paragraph,-p.235, paragraph bridging left and right columns, and Figs. 1H-I). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have screened for lung cancer by the screening method of Shamsuddin1 in view of Shamsuddin2 and Carte in asymptomatic patients and to treat the asymptomatic patient, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to because In teaches asymptomatic patients that were treated with surgery showed longer survival times than symptomatic patients. Thus, the person of ordinary skill would have been motivated to detect and treat lung cancer as soon as possible, yielding predictable results. Therefore, it would have been obvious to one of ordinary skill in the art to modify the cancer or precancer screening method of Shamsuddin to test for lung cancer in asymptomatic patients.
In Applicant’s Remarks, see paragraph bridging pp.12-13, with regards to the double patenting rejections, Applicant reasserts the arguments set forth above. This is not found persuasive. Applicant’s arguments are addressed in the reply set forth above.
Conclusion
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/J.P.S./Examiner, Art Unit 1657