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 .
Claim Status
Claims 1-7 are currently pending in this US patent application and were examined on their merits.
Information Disclosure Statement
The information disclosure statements filed in this application on 05/02/2023, 10/04/2024, and 05/14/2025 have been received and considered.
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.
Claims 3-5 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 “reduced” in claims 3-4 is a relative term which renders the claim indefinite. The term “reduced” 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. What level of protein content in a blood sample qualifies as “reduced?” As such, one of ordinary skill in the art would be unable to determine the metes and bounds of the claimed invention, rendering it indefinite.
Because claim 5 depends from claim 4 and does not provide further clarification of the indefinite language therein, this claim is also indefinite. Therefore, claims 3-5 are rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, the Examiner has interpreted the “reduced” protein content of claims 3-5 to be any level of protein.
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.
Claims 1-4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over US patent application publication 2017/0016906 filed by Hirotsu et al., published 01/19/2017.
Hirotsu teaches the detection of cancer by the chemotaxis of nematodes in response to subject-derived bio-related substances (see entire document, including page 1, paragraph 0013-0014; cf. claim 1). The cancer may be gastric cancer, colon/rectal cancer, or gastrointestinal stromal cancer, among other types (page 5, paragraph 0073; cf. claims 6-7). The bio-related substance may be blood (page 7, paragraph 0109; cf. claims 1-3; the Examiner notes that blood intrinsically contains serum and plasma, and claim 2 does not preclude other blood substances from being present in the sample). A processed sample is preferably used, and centrifugation may be used to process samples prior to evaluation with nematodes (page 7, paragraphs 0109-0111; cf. claims 3-4; the Examiner notes that centrifuging a blood sample would remove blood cells and result in the intrinsic removal of at least some protein from the sample; claim 4 does not require that the deproteinization be to any particular degree).
However, Hirotsu does not explicitly teach the use of blood or centrifuged blood as the patient sample evaluated for the presence of cancer as recited in the instant claims.
While Hirotsu does not explicitly teach the use of blood or centrifuged blood as the patient sample evaluated for the presence of cancer as recited in the instant claims, it would have been obvious to one of ordinary skill in the art to do so because Hirotsu suggests the use of blood or centrifuged blood as the patient sample evaluated for the presence of cancer. One of ordinary skill in the art would have a reasonable expectation that using the blood suggested by Hirotsu as the patient sample in the method of Hirotsu would successfully result in the detection of cancer-related substances in the sample via nematode chemotaxis.
Therefore, claims 1-4 and 6-7 are rendered obvious by Hirotsu and are rejected under 35 U.S.C. 103.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over US patent application publication 2017/0016906 filed by Hirotsu et al., published 01/19/2017, in view of Whitlam et al., J. Pharm. Sci. 70(2): 146-150 (1981).
As discussed above, claims 1-4 and 6-7 are rendered obvious by Hirotsu. In addition, Hirotsu teaches that the subject sample may be filtered prior to use and that such filtration does not affect the reaction of the nematode to the sample (page 7, paragraph 0110). In addition, the concentration of the odorant is important for the nematode’s response to it (page 6, paragraph 0095). However, Hirotsu does not teach that the filtration process is ultrafiltration as recited in instant claim 5.
Whitlam teaches that ultrafiltration can be used to remove serum proteins from blood samples to better estimate the fraction of free small molecules in plasma and whole blood (see entire document, including page 146, right column, paragraph 2-4; cf. claim 5; the Examiner notes that ultrafiltration of blood would intrinsically result in the deproteinization of the blood sample to at least some degree).
While Hirotsu does not teach that the filtration process used to process the blood sample is ultrafiltration as recited in instant claim 5, it would have been obvious to one of ordinary skill in the art to do so because Hirotsu teaches that sample filtration does not interfere with the cancer detection method and that the concentration of the odorant detected by the nematodes affects the response of the nematodes. In addition, Whitlam teaches that ultrafiltration may be used on blood samples to allow for a more accurate determination of the concentration of free (i.e., non-protein-bound) small molecules in the sample. One of ordinary skill in the art would have a reasonable expectation that using the ultrafiltration of Whitlam on the blood sample of Hirotsu prior to evaluation with the nematodes would successfully result in the production of a blood sample that could be evaluated for the presence of cancer-related molecules by observing nematode chemotaxis.
Therefore, claims 1-7 are rendered obvious by Hirotsu in view of Whitlam and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11719698 in view of international patent application WO 2017/081750 filed by Sakairi et al., published 05/18/2017 (cited on the IDS filed 05/02/2023; please note that citations for this reference listed herein correspond to the English translation attached to this Office action), and Whitlam et al., J. Pharm. Sci. 70(2): 146-150 (1981). The claims of ‘698 differ from the instant claims by reciting that the tested biological sample is urine instead of blood as instantly recited. However, regarding claims 1-4 and 6-7, Sakairi teaches that blood may be used in assays of nematode taxis for cancer detection (see entire document, including page 1, paragraph 1, and page 14, paragraph 6). Regarding claim 5, Whitlam teaches that ultrafiltration may be used to remove substances from blood (see citations presented above). As such, the instant claims are ‘rendered obvious’ by the cited claims of ‘698 in view of Sakairi and Whitlam and are rejected on the ground of nonstatutory double patenting.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12019068 in view of international patent application WO 2017/081750 filed by Sakairi et al., published 05/18/2017 (cited on the IDS filed 05/02/2023; please note that citations for this reference listed herein correspond to the English translation attached to this Office action), and Whitlam et al., J. Pharm. Sci. 70(2): 146-150 (1981). The claims of ‘068 differ from the instant claims by reciting that the tested biological sample is urine instead of blood as instantly recited. However, regarding claims 1-4 and 6-7, Sakairi teaches that blood may be used in assays of nematode taxis for cancer detection (see entire document, including page 1, paragraph 1, and page 14, paragraph 6). Regarding claim 5, Whitlam teaches that ultrafiltration may be used to remove substances from blood (see citations presented above). As such, the instant claims are ‘rendered obvious’ by the cited claims of ‘068 in view of Sakairi and Whitlam and are rejected on the ground of nonstatutory double patenting.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11479800 in view of international patent application WO 2017/081750 filed by Sakairi et al., published 05/18/2017 (cited on the IDS filed 05/02/2023; please note that citations for this reference listed herein correspond to the English translation attached to this Office action), and Whitlam et al., J. Pharm. Sci. 70(2): 146-150 (1981). The claims of ‘800 differ from the instant claims by reciting that the tested biological sample is urine instead of blood as instantly recited. However, regarding claims 1-4 and 6-7, Sakairi teaches that blood may be used in assays of nematode taxis for cancer detection (see entire document, including page 1, paragraph 1, and page 14, paragraph 6). Regarding claim 5, Whitlam teaches that ultrafiltration may be used to remove substances from blood (see citations presented above). As such, the instant claims are ‘rendered obvious’ by the cited claims of ‘800 in view of Sakairi and Whitlam and are rejected on the ground of nonstatutory double patenting.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12493040 in view of international patent application WO 2017/081750 filed by Sakairi et al., published 05/18/2017 (cited on the IDS filed 05/02/2023; please note that citations for this reference listed herein correspond to the English translation attached to this Office action), and Whitlam et al., J. Pharm. Sci. 70(2): 146-150 (1981). The claims of ‘040 differ from the instant claims by reciting that the tested biological sample is urine instead of blood as instantly recited. However, regarding claims 1-4 and 6-7, Sakairi teaches that blood may be used in assays of nematode taxis for cancer detection (see entire document, including page 1, paragraph 1, and page 14, paragraph 6). Regarding claim 5, Whitlam teaches that ultrafiltration may be used to remove substances from blood (see citations presented above). As such, the instant claims are ‘rendered obvious’ by the cited claims of ‘040 in view of Sakairi and Whitlam and are rejected on the ground of nonstatutory double patenting.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Erin M. Bowers/Primary Examiner, Art Unit 1653 01/08/2026