DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Acknowledgement is made of Applicant’s claim for foreign priority under 35 USC 119(a)-(d) to
Japanese Application JP2023-080930, filed 16 May 2023, and JP2022-088489, filed 31 May 2022. Receipt is acknowledged of certified copies of papers, in a non-English language, required by 37 CFR 1.55.
Status of the Claims
Claims 1-15, of record 24 May 2023, are pending. Therefore, prosecution on the merits commences for claims 1-15.
Specification
The abstract of the disclosure is objected to because it recites “[a]n object of the present disclosure to provide…” instead of “[a]n object of the present disclosure is to provide…”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 7-8 and 13-14 are objected to because of the following informalities:
Regarding claims 7 and 13: The instant claims are objected to for each reciting “wherein the squamous epithelial cells are derived from human oral cavity” instead of “wherein the squamous
epithelial cells are derived from a human oral cavity”.
Appropriate correction is required.
Regarding claims 8 and 14: The instant claims are objected to for each reciting “wherein the squamous epithelial cells are surface mucous cells derived from bovine stomach, cervine stomach, sheep stomach, or porcine stomach” instead of “wherein the squamous epithelial cells are surface mucous cells derived from a bovine stomach, a cervine stomach, a sheep stomach, or a porcine stomach”.
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.
Claim 9 is 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.
Regarding claim 9: The instant claim recites the limitation "the bovine stomach" in Line 1. There is insufficient antecedent basis for this limitation in the claim, as there is no prior recitation of a bovine stomach within the instant claim.
Appropriate correction is required.
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 9 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.
Regarding claim 9: The instant claim as currently written is dependent upon itself. Therefore,
the instant claim does not make reference to a claim previously set forth, and is incorrectly dependent.
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.
Appropriate correction is required.
For purposes of compact prosecution, the Examiner will interpret the claim as being dependent
upon instant claim 8.
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 1-6 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Das (US 2020/0371086 A1, of record on IDS filed 24 May 2023) in view of Nakajima et al (US 2019/0101742 A1, of record on IDS filed 24 May 2023).
Das is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2), with a publication date of 26 November 2020. Nakajima et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2), with a publication date of 04 April 2019 – which is greater than one year prior to the effective filing date of the instant invention.
Regarding claims 1-2: Das discloses quality control substances for use with a microscopy-based urine sediment analyzer, as well as methods of improving the detection of an analyte in a urine sample from a subject by using the quality control substances (Abstract; Paragraphs [0002], [0004]-[0006], [0016]-[0018], [0028], [0083]).
As such, Das discloses that common sediments found within urine and indicative of pathological conditions include red blood cells, white blood cells, crystals, bacteria, yeast, pathological casts, or non-squamous epithelial cells (Paragraphs [0027]-[0028], [0043]). Das further discloses within an embodiment of the invention that yeast cells can be included in the quality control substance to serve as a morphological control for yeast present in a urine sample (Paragraphs [0034], [0041], [0043], [0045]). In another embodiment, Das further discloses that human cancer cells can be a quality control substance to serve as a morphological control for non-squamous epithelial cells present in a urine sample (Paragraphs [0032], [0036]-[0039], [0047]-[0066]).
Das does not disclose that the quality control substance is squamous epithelial cells derived from a mammal, as required by instant claim 1.
Nakajima et al, however, disclose the testing of urine for analytes using an analysis apparatus, wherein the analytes include an erythrocyte, a leukocyte, a squamous epithelial cell, other epithelial cells, a cast, a crystal, and a bacterium (Abstract; Paragraphs [0025], [0060]-[0066]).
Therefore, it would have been prima facie obvious to modify the urinalysis method of Das such that the presence of squamous epithelial cells is detected within a urine sample using a squamous epithelial cell as a quality control substance, as detailed in Nakajima et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to analyze a well-known analyte within urine samples utilizing a morphologically identical quality control substance – i.e., the same cell type – and would have had a reasonable expectation of success given that the disclosures of Das and Nakajima et al are both concerned with the analysis of sediment within urine samples. More specifically, the ordinary artisan would have reasonably understood that mammalian squamous epithelial cells can serve as a quality control substance for squamous epithelial cells in urine given the sedimentary squamous epithelial cell parameters provided in Nakajima et al (Paragraphs [0060]-[0066]). See MPEP § 2143(I)(G).
Consequently, Das as modified by Nakajima et al render obvious a method of analyzing urine with a microscopy-based urine sediment analyzer utilizing mammalian squamous epithelial cells as a quality control substance to improve the detection accuracy (claim 2). This therefore renders obvious the method of instant claim 1.
Regarding claims 3-5: Following the discussion of claim 1, Das further discloses that the quality control substances are fixed (claim 5) and stored in phosphate-buffered saline (claims 3-4) (Paragraphs [0032], [0058]-[0064]). This therefore reads on the methods of the instant claims.
Regarding claim 6: Following the discussion of claim 1, Das further discloses that the epithelial cell quality control substances are derived from humans (Paragraphs [0032], [0057]-[0059]). This therefore reads on the method of the instant claim.
Regarding claims 10-11: As aforementioned in the discussion of claim 1, Das as modified by Nakajima et al render obvious a method of analyzing urine with a microscopy-based urine sediment analyzer utilizing mammalian squamous epithelial cells as a quality control substance to improve the detection accuracy.
Nakajima et al further disclose that the urine sediment analyzer is capable of counting the number of sediment components within a urine sample (Paragraphs [0005], [0007], [0084]-[0087], [0095]-[0096], [0100], [0106]-[0108], [0112]-[0113]).
Therefore, it would have been prima facie obvious to have modified the urinalysis method of Das such that the concentration of a mammalian squamous epithelial cell control is measured and then utilized as a reference to the concentration of sedimentary squamous epithelial cell in a urine sample, as suggested in Nakajima et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to determine and enhance the accuracy of the measured samples by comparing them to a known reference value, and would have had a reasonable expectation of success given the counting protocols outlined in Nakajima et al. See MPEP § 2143(I)(G).
Consequently, Das as modified by Nakajima et al render obvious a method of analyzing a urine sample (claim 11), wherein a concentration of a mammalian squamous epithelial cell quality control substance is measured and then utilized as a reference to the concentration of sedimentary squamous epithelial cell within the urine sample. This therefore renders obvious the method of instant claim 10.
Regarding claim 12: Following the discussion of claim 10, Das further discloses that the epithelial cell quality control substances are derived from humans (Paragraphs [0032], [0057]-[0059]). This therefore reads on the method of the instant claim.
Claims 1-7 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Das (US 2020/0371086 A1, of record on IDS filed 24 May 2023) in view of Nakajima et al (US 2019/0101742 A1, of record on IDS filed 24 May 2023), and further in view of Hustler et al (Exp Cell Res, 2018).
The discussion of Das as modified by Nakajima et al regarding claims 1 and 10 can be observed
above and is relied upon herein, the content of which is incorporated in its entirety. Das as modified by Nakajima et al render obvious claims 1-6 and 10-12. Hustler et al is considered prior art under 35 USC 102(a)(1).
Regarding claims 7 and 13: Following the discussion of claims 1 and 10 above, Das further discloses that the quality control substances are morphologically matched to the sedimentary analytes found within the analyzed urine samples (Paragraphs [0003], [0005], [0032]-[0035], [0038], [0071]).
Das further discloses that the epithelial cell quality control substances can be derived from humans (Paragraphs [0032], [0057]-[0059]).
The combination of Das and Nakajima et al fail to teach that the squamous epithelial cell controls are mucosal epithelial cells derived from a human oral cavity, as required by instant claims 7 and 13.
Hustler et al, however, disclose that squamous epithelial cells derived from the buccal mucosa of human subjects are essentially morphologically identical to human urothelial cells (Pages 284-286, 288, 293; Figure 1).
Therefore, it would have been prima facie obvious to have modified the urinalysis method of Das in view of Nakajima et al such that the squamous epithelial cell quality control substances are mucosal epithelial cells derived from human buccal tissue, as suggested in Hustler et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to utilize a squamous epithelial cell that is morphologically matched to the urothelial cells found in urine, and would have had a reasonable expectation of success given the outlined protocols in Das relating to the usage of quality control substances that are morphologically matched to the sedimentary counterparts. See MPEP § 2143(I)(G).
Consequently, Das as modified by Nakajima et al and Hustler et al render obvious a method of analyzing a urine sample, wherein the squamous epithelial cell quality control substances are mucosal epithelial cells derived from human buccal tissue. This therefore renders obvious the methods of instant claims 7 and 13.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Das (US 2020/0371086 A1, of record on IDS filed 24 May 2023) in view of Nakajima et al (US 2019/0101742 A1, of record on IDS filed 24 May 2023) and Hustler et al (Exp Cell Res, 2018), and further in view of Xu et al (PLoS One, 2014).
The discussion of Das as modified by Nakajima et al regarding claims 1 and 10 can be observed
above and is relied upon herein, the content of which is incorporated in its entirety. The discussion of Das as modified by Nakajima et al and Hustler et al regarding claims 7 and 13 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Das as modified by Nakajima et al render obvious claims 1-6 and 10-12. Das as modified by Nakajima et al and Hustler et al render obvious claims 1-7 and 10-13. Xu et al is considered prior art under 35 USC 102(a)(1).
Regarding claims 8-9 and 14-15: As aforementioned in the discussion of claims 7 and 13 above, Das as modified by Nakajima et al and Hustler et al render obvious a method of analyzing a urine sample, wherein the squamous epithelial cell quality control substances are mucosal epithelial cells derived from human buccal tissue.
Hustler et al further disclose that the buccal-derived mucosal epithelial cells are approximately 50 microns in size, exhibit a ‘cobblestone’ appearance, and comprise a dark-round nucleus (Pages 286-288; Figure 1C).
The combination of Das, Nakajima et al, and Hustler et al fail to teach that squamous epithelial cell quality control substances are surface mucous cells derived from a bovine omasum, as required by instant claims 8-9 and 14-15.
Xu et al, however, disclose that surface omasal epithelial cells are approximately 50 microns in size, exhibit a typical ‘cobblestone’ appearance, and comprise a dark-round nucleus (Pages 1-3, 6-7; Figures 2-3, 6).
Therefore, it would have been prima facie obvious to have substituted the buccal-derived mucosal epithelial cell quality controls of Das as modified by Nakajima et al and Hustler et al with the surface omasal epithelial cells of Xu et al, as doing so would have been a simple substitution of one morphologically matched squamous epithelial cell control for another. See MPEP § 2143(I)(B). One of ordinary skill in the art before the effective filing date of the invention would have recognized that the two cell types are functionally comparable, as both the buccal- and omasal-derived squamous epithelial cells comprise the same morphological characteristics, and thereby would have been able to substitute the two cell types with predictable results.
Consequently, Das as modified by Nakajima et al, Hustler et al, and Xu et al render obvious a method of analyzing a urine sample, wherein the squamous epithelial cell quality control substances are surface mucosal epithelial cells derived from bovine omasum (claims 9 and 15). This therefore renders obvious the methods of instant claims 8 and 14.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner
should be directed to ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
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