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
The amendment of 04/15/2026 has been entered. Claims 1 and 5-15 are currently pending in this US patent application and were examined on their merits.
Withdrawn Rejections
All rejections of claims 2-4 set forth in the previous Office action are withdrawn in light of the amendment of 04/15/2026, which canceled these claims.
The rejection of the claims under 35 U.S.C. 112(b) for being indefinite as set forth in the previous Office action is withdrawn in light of the amendment of 04/15/2026, which corrected the indefinite language in the claims.
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 and 6-7 remain rejected, and claim 11 is newly rejected as necessitated by amendment 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.
Please note that the rejection of claims 1 and 6-7 has been slightly amended as a result of the movement of limitations from previous claims into claim 1 with the amendment of 04/15/2026.
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. claim 1; the Examiner notes that blood intrinsically contains serum and plasma, and the claims do 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. claim 1; 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 1 does not require that the deproteinization be to any particular degree). Samples may be diluted to multiple different concentrations to produce test samples of varying dilution factors prior to the chemotaxis assay (paragraph 0200; cf. claim 11).
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, 6-7, and 11 are rendered obvious by Hirotsu and are rejected under 35 U.S.C. 103.
Claims 1 and 5-7 remain rejected, and claims 11-12 are newly rejected as necessitated by amendment 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, 6-7, and 11 are rendered obvious by Hirotsu. The portion of Hirotsu used above to render claim 11 obvious would apply equally to the identical limitation in claim 12. 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, 5-7, and 11-12 are rendered obvious by Hirotsu in view of Whitlam and are rejected under 35 U.S.C. 103.
Claims 1 and 5-7 remain rejected, and claims 8-15 are newly rejected as necessitated by amendment 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), and Shihabi, J. Chromatog. A 652: 471-475 (1993).
As discussed above, claims 1, 5-7, and 11-12 are rendered obvious by Hirotsu in view of Whitlam. The portion of Hirotsu used above to render claims 11-12 obvious would apply equally to the identical limitations in claims 13-15. However, Hirotsu and Whitlam do not teach that the deproteinization is performed using acetonitrile.
Shihabi teaches that acetonitrile deproteinization may be used to remove serum proteins, which interfere with the detection of small molecules, from blood samples (see entire document, including page 471, left column, paragraph 1, to right column, paragraph 2; cf. claims 8-10).
While Hirotsu and Whitlam do not teach that the process used to reduce the protein concentration in the blood sample is acetonitrile precipitation as recited in instant claims 8-10 in the method of processing a blood sample to reduce protein concentrations prior to assaying the sample for cancer-related molecules by nematode chemotaxis, it would have been obvious to one of ordinary skill in the art to do so because Shihabi teaches that acetonitrile precipitation may be used to remove serum proteins from blood samples, thereby removing an ingredient that may interfere with measurements of the small molecules by binding them. One of ordinary skill in the art would have a reasonable expectation that using the acetonitrile of Shihabi to reduce protein concentrations as taught by 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 and 5-15 are rendered obvious by Hirotsu in view of Whitlam and Shihabi 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 and 5-7 remain 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 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; the Examiner notes that ultrafiltering a blood sample would intrinsically result in the reduction of the protein content to at least some degree). 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 and 5-7 remain rejected, and claims 8-15 are newly rejected as necessitated by amendment 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), Whitlam et al., J. Pharm. Sci. 70(2): 146-150 (1981), US patent application publication 2017/0016906 filed by Hirotsu et al., published 01/19/2017, and Shihabi, J. Chromatog. A 652: 471-475 (1993).
As discussed above, claims 1 and 5-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of ‘698 in view of Sakairi and Whitlam. The limitations of acetonitrile deproteinization and making multiple dilutions as recited in instant claims 8-15 are taught in Shihabi and Hirotsu, respectively (see citations presented above). As such, claims 1 and 5-15 are ‘rendered obvious’ by the cited claims of ‘698 in view of Sakairi, Whitlam, Hirotsu, and Shihabi and are rejected on the ground of nonstatutory double patenting.
Claims 1 and 5-7 remain 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; the Examiner notes that ultrafiltering a blood sample would intrinsically result in the reduction of the protein content to at least some degree). 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 and 5-7 remain rejected, and claims 8-15 are newly rejected as necessitated by amendment 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), Whitlam et al., J. Pharm. Sci. 70(2): 146-150 (1981), US patent application publication 2017/0016906 filed by Hirotsu et al., published 01/19/2017, and Shihabi, J. Chromatog. A 652: 471-475 (1993).
As discussed above, claims 1 and 5-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of ‘068 in view of Sakairi and Whitlam. The limitations of acetonitrile deproteinization and making multiple dilutions as recited in instant claims 8-15 are taught in Shihabi and Hirotsu, respectively (see citations presented above). As such, claims 1 and 5-15 are ‘rendered obvious’ by the cited claims of ‘068 in view of Sakairi, Whitlam, Hirotsu, and Shihabi and are rejected on the ground of nonstatutory double patenting.
Claims 1 and 5-7 remain 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; the Examiner notes that ultrafiltering a blood sample would intrinsically result in the reduction of the protein content to at least some degree). 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 and 5-7 remain rejected, and claims 8-15 are newly rejected as necessitated by amendment 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), Whitlam et al., J. Pharm. Sci. 70(2): 146-150 (1981), US patent application publication 2017/0016906 filed by Hirotsu et al., published 01/19/2017, and Shihabi, J. Chromatog. A 652: 471-475 (1993).
As discussed above, claims 1 and 5-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of ‘800 in view of Sakairi and Whitlam. The limitations of acetonitrile deproteinization and making multiple dilutions as recited in instant claims 8-15 are taught in Shihabi and Hirotsu, respectively (see citations presented above). As such, claims 1 and 5-15 are ‘rendered obvious’ by the cited claims of ‘800 in view of Sakairi, Whitlam, Hirotsu, and Shihabi and are rejected on the ground of nonstatutory double patenting.
Claims 1 and 5-7 remain 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; the Examiner notes that ultrafiltering a blood sample would intrinsically result in the reduction of the protein content to at least some degree). 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.
Claims 1 and 5-7 remain rejected, and claims 8-15 are newly rejected as necessitated by amendment 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), Whitlam et al., J. Pharm. Sci. 70(2): 146-150 (1981), US patent application publication 2017/0016906 filed by Hirotsu et al., published 01/19/2017, and Shihabi, J. Chromatog. A 652: 471-475 (1993).
As discussed above, claims 1 and 5-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of ‘040 in view of Sakairi and Whitlam. The limitations of acetonitrile deproteinization and making multiple dilutions as recited in instant claims 8-15 are taught in Shihabi and Hirotsu, respectively (see citations presented above). As such, claims 1 and 5-15 are ‘rendered obvious’ by the cited claims of ‘040 in view of Sakairi, Whitlam, Hirotsu, and Shihabi and are rejected on the ground of nonstatutory double patenting.
Response to Arguments
Applicant has traversed the above rejection of the claims under 35 U.S.C. 103 as being unpatentable over Hirotsu. Applicant states that Hirotsu does not disclose or suggest subjecting the blood sample to a deproteinization treatment to obtain a blood sample having a reduced protein content, compared to that before the deproteinization treatment, as recited in amended claim 1 (remarks, pages 6-8). This argument has been fully considered but has not been found persuasive.
The Examiner notes that, as discussed above and in the previous Office action, Hirotsu suggests a process of centrifuging blood prior to the chemotaxis assay. Centrifuging blood, which would result in the removal of the protein-containing blood cells from whole blood, would reduce the protein content of the blood sample. Instant claim 1 does not require any particular deproteinization treatment or that the treated sample exhibit a reduction of any particular degree, and so any reduction of protein content, even by a single molecule (which would certainly be achieved by centrifugation as suggested by Hirotsu), is sufficient to satisfy the limitations of claim 1.
Applicant states that Whitlam does not remedy this deficiency because Whitlam’s field of pharmacokinetics is fundamentally different from nematode chemotaxis assays for cancer detection. Applicant states that the components responsible for attracting nematodes in the instantly recited assay are unidentified, and so one of ordinary skill in the art would not have a reasonable expectation that performing the ultrafiltration of Whitlam would not remove the unknown attractant(s) from the blood sample (remarks, pages 8-9). This argument has been fully considered but has not been found persuasive.
The Examiner notes that, as discussed above and in the previous Office action, 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 (emphasis added). 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. Stated differently, Whitlam teaches that ultrafiltration can remove proteins from blood samples, which allows for better detection of the small molecules in the blood samples because they are not bound by the proteins. One of ordinary skill in the art would be motivated to perform this step because Hirotsu teaches that the concentration of the substance detected by the nematodes in the sample affects the response of the nematodes to the sample. As such, having a stable concentration and making sure that the odorants are not bound to proteins but are free to be detected by the nematodes would provide motivation for one of ordinary skill in the art. In addition, 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. According to the teachings of Hirotsu, filtration does not interfere with the cancer detection method. As such, contrary to Applicant’s assertion, one of ordinary skill in the art would certainly not expect filtration methods, such as those taught by Whitlam, to remove the attractant(s) from the blood sample of Hirotsu because of Hirotsu’s explicit disclosure.
Therefore, the Examiner has maintained the rejections presented above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 07/02/2026
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