Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 1-16, 22 and 26-33 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.
On lines 4-5 of claim 1, the phrase “comparing levels of at least two lipid analytes from a biological sample obtained from the subject to control levels of at least two lipid analytes” is indefinite since it is not clear whether the “control levels of at least two lipid analytes” in this phrase are control levels of the same at least two lipid analytes measured and obtained from the biological sample of the subject. It is suggested to change this phrase to -- comparing levels of at least two lipid analytes from a biological sample obtained from the subject to control levels of the at least two lipid analytes--. On line 11 of claim 1, the phrase “changing the treatment” lacks antecedent basis since the treatment to be changed is not positively recited in claim 1 until after this phrase (i.e. “wherein the treatment to be changed comprises a lipid-lowering medication” which is recited after the phrase “changing the treatment of the subject” on lines 11-12 of claim 1).
On lines 4-5 of claim 14, the phrase “comparing levels of at least two lipid analytes from a biological sample obtained from the subject to control levels of at least two lipid analytes” is indefinite since it is not clear whether the “control levels of at least two lipid analytes” in this phrase are control levels of the same at least two lipid analytes measured and obtained from the biological sample of the subject. It is suggested to change this phrase to -- comparing levels of at least two lipid analytes from a biological sample obtained from the subject to control levels of the at least two lipid analytes--. On line 11 of claim 14, the phrase “changing the treatment” lacks antecedent basis since the treatment to be changed is not positively recited in claim 1 until after this phrase (i.e. “wherein the treatment to be changed comprises a lipid-lowering medication” which is recited after the phrase “changing the treatment of the subject” on lines 11-12 of claim 14).
On line 2 of claim 28, the phrase “changing the treatment” lacks antecedent basis since the treatment to be changed is not positively recited in claim 28 until after this phrase (i.e. “wherein the treatment to be changed comprises a lipid-lowering medication” which is recited after the phrase “changing the treatment of the subject” on lines 2-3 of claim 28). On lines 5-6 of claim 28, the phrase “in which levels of at least two lipid analytes from a biological sample obtained from the subject were compared to control levels of at least two lipid analytes” is indefinite since it is not clear whether the “control levels of at least two lipid analytes” in this phrase are control levels of the same at least two lipid analytes measured and obtained from the biological sample of the subject. It is suggested to change this phrase to -- in which levels of at least two lipid analytes from a biological sample obtained from the subject were compared to control levels of the at least two lipid analytes--.
On line 2 of claim 29, the phrase “changing the treatment” lacks antecedent basis since the treatment to be changed is not positively recited in claim 29 until after this phrase (i.e. “wherein the treatment to be changed comprises a lipid-lowering medication” which is recited after the phrase “changing the treatment of the subject” on lines 2-3 of claim 29). On lines 5-6 of claim 29, the phrase “in which levels of at least two lipid analytes from a biological sample obtained from the subject were compared to control levels of at least two lipid analytes” is indefinite since it is not clear whether the “control levels of at least two lipid analytes” in this phrase are control levels of the same at least two lipid analytes measured and obtained from the biological sample of the subject. It is suggested to change this phrase to -- in which levels of at least two lipid analytes from a biological sample obtained from the subject were compared to control levels of the at least two lipid analytes--.
Claims 30 and 31 are indefinite since it is not clear in what the levels of lipid analytes in a subject are determined in the method. Are the levels of the at least two lipid analytes determined in a biological sample obtained from the subject? It is suggested to change the phrase “A method for determining levels of lipid analytes in a subject, the method comprising: determining levels of at least two lipid analytes in the subject” on lines 1-2 of claims 30 and 31 to -- A method for determining levels of lipid analytes in a biological sample obtained from a subject, the method comprising: determining levels of at least two lipid analytes in the biological sample obtained from the subject--.
On line 2 of claim 32, the phrase “changing the treatment” lacks antecedent basis since the treatment to be changed is not positively recited in claim 32 until after this phrase (i.e. “wherein the treatment to be changed comprises a lipid-lowering medication” which is recited after the phrase “changing the treatment of the subject” on lines 2-3 of claim 32).
On line 2 of claim 33, the phrase “changing the treatment” lacks antecedent basis since the treatment to be changed is not positively recited in claim 33 until after this phrase (i.e. “wherein the treatment to be changed comprises a lipid-lowering medication” which is recited after the phrase “changing the treatment of the subject” on lines 2-3 of claim 33).
Inventorship
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
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 1-16, 22 and 26-33 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9,110,086. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-7 in U.S. Patent no. 9,110,086 recite a method of treatment of a subject vulnerable with respect to plaques by measuring at least two lipid analytes in a sample obtained from a subject, wherein the at least two lipid analytes comprise modCer 731.6 and DHC 18:1, but also comprise any lipid analyte listed in Table 1 of the specification (see claim 4 in U.S. 9,110,086), and Table 1 lists both LPC 20:0 and LPC 22:6 (see lipid analytes 120 and 121 in Table 1 on page 11 of the instant specification) as being lipid analytes measured in a biological sample obtained from a subject in order to determine whether the subject is vulnerable with respect to plaques or has heart disease, comparing the measured levels of the at least two lipid analytes to control levels of the at least two lipid analytes in order to determine whether the subject is vulnerable or non-vulnerable with respect to plaques (i.e. plaque rupture), and administering or providing a therapeutic treatment to the subject based on whether the subject is determined to be vulnerable or non-vulnerable with respect to plaques. While claim 1 in U.S. Patent 9,110,086 does not recite that the therapeutic treatment of the subject determined to be vulnerable with respect to plaques comprises administering a lipid-lowering medication to the subject or changing a lipid-lowering medication that the subject is currently being treated with, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the therapeutic treatment to the subject recited in claims 1-7 of U.S. Patent 9,110,086 indicated as being vulnerable with respect to plaques by administering a lipid-lowering medication to the subject or changing a lipid-lowering medication that the subject is currently being treated with because lipid-lowering medications, such as statins (instant claims 26-27), are a well-recognized and often-used therapeutic class of drugs used to clinically treat the condition identified by the claims in U.S. Patent 9,110,086 (i.e. vulnerability to plaques).
With respect to instant claims 14-16, 22, 29 and 33, while the claims in U.S. Patent 9,110,086 fail to recite that the method can also be used to treat subjects indicated as having heart disease, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the same steps of the method recited in U.S. Patent 9,110,086 to treat a subject indicated as having heart disease by measuring at least two or more lipid analytes listed in Table 1 of the instant specification, including LPC 20:0 and LPC 22:6, and comparing the measured levels to control levels of the at least two or more lipid analytes because it is well-known that atherosclerosis is a common cause of heart disease in a subject and that atherosclerosis develops in a subject due to the formation of fibriolipid plaques within the intima of the arterial wall, thus leading to a causative association between vulnerable plaques in a subject and heart disease (see paragraphs 0004-0006 in the Background section on pages 1-2 of the instant specification).
With respect to instant claims 2-3, 6 and 15, it is noted that claims 2-3 in U.S. Patent no. 9,110,086 also recite comparing the measured at least two lipid analytes to control levels of the same at least two lipid analytes measured in either a first control sample from a subject that is known to be vulnerable to plaques, a second control sample that is known to be non-vulnerable to plaques, or a healthy control sample from a healthy subject.
With regards to claims 4-5, 7-12 and 16, it is noted that claims 4-6 in U.S. Patent no. 9,110,096 also recite that at least 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,1 4, 15 or 16 lipid analytes listed in Table 1 of the instant specification are measured in the method, and that these multiple lipid analytes comprise any of the modified or non-modified lipid analytes listed in Table 1, such as LPC 20:0, LPC 22:6, modCER 731.6 and DHC 18:1.
With regards to claims 13 and 22, it is noted that claim 7 in U.S. Patent no. 9,110,086 also recites that the levels of the lipid analytes are used in combination with one or more traditional risk factors of coronary artery disease (CAD) such as age, sex, smoker, diabetes, hypertension, etc.
With regards to claims 30-31, it is noted that the combination of claims 1 and 4 in U.S. 9,110,086 recite the steps of determining levels of at least two lipid analytes included in Table 1 in the instant specification, wherein Table 1 lists both LPC 20:0 and LPC 22:6 as being possible lipid analytes to measure in the method, in a sample obtained from a subject as a risk factor of being vulnerable with respect to plaques and with respect to heart disease as a necessary step to provide therapeutic treatment to the subject, and thus, recite the same methods recited in instant claims 30 and 31.
Claims 1-16, 22 and 26-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,255,935. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-11 in U.S. Patent no. 9,255,935 recite a method of treatment of a subject vulnerable with respect to plaques by measuring at least two lipid analytes in a sample obtained from a subject, wherein the at least two lipid analytes comprise alkylphosphatidylcholine APC 32:1, APC 32:0, APC 34:2, APC 34:1, APC 34:0, APC 36:5, APC 36:4, APC 36:3, APC 36:2, APC 36:1, APC 36:0, APC 38:6, APC 38:5, APC 38:4, APC 38:3 and APC 38:2, but also comprise any lipid analyte listed in Table 1 of the specification (see claims 4 and 10 in U.S. 9,255,935), and Table 1 lists both LPC 20:0 and LPC 22:6 (see lipid analytes 120 and 121 in Table 1 on page 11 of the instant specification) as being lipid analytes measured in a biological sample obtained from a subject in order to determine whether the subject is vulnerable with respect to plaques or has heart disease, comparing the measured levels of the at least two lipid analytes to control levels of the at least two lipid analytes in order to determine whether the subject is vulnerable or non-vulnerable with respect to plaques (i.e. plaque rupture), and administering or providing a therapeutic treatment to the subject based on whether the subject is determined to be vulnerable or non-vulnerable with respect to plaques. While claims 1 and 7 in U.S. Patent 9,255,935 do not recite that the therapeutic treatment of the subject determined to be vulnerable with respect to plaques comprises administering a lipid-lowering medication to the subject or changing a lipid-lowering medication that the subject is currently being treated with, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the therapeutic treatment to the subject recited in claims 1-11 of U.S. Patent 9,255,935 indicated as being vulnerable with respect to plaques by administering a lipid-lowering medication to the subject or changing a lipid-lowering medication that the subject is currently being treated with because lipid-lowering medications, such as statins (instant claims 26-27), are a well-recognized and often-used therapeutic class of drugs used to clinically treat the condition identified by the claims in U.S. Patent 9,255,935 (i.e. vulnerability to plaques).
With respect to instant claims 14-16, 22, 29 and 33, while the claims in U.S. Patent 9,255,935 fail to recite that the method can also be used to treat subjects indicated as having heart disease, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the same steps of the method recited in U.S. Patent 9,255,935 to treat a subject indicated as having heart disease by measuring at least two or more lipid analytes listed in Table 1 of the instant specification, including LPC 20:0 and LPC 22:6, and comparing the measured levels to control levels of the at least two or more lipid analytes because it is well-known that atherosclerosis is a common cause of heart disease in a subject and that atherosclerosis develops in a subject due to the formation of fibriolipid plaques within the intima of the arterial wall, thus leading to a causative association between vulnerable plaques in a subject and heart disease (see paragraphs 0004-0006 in the Background section on pages 1-2 of the instant specification).
With respect to instant claims 2-3, 6 and 15, it is noted that claims 2-3 and 8-9 in U.S. Patent no. 9,255,935 also recite comparing the measured at least two lipid analytes to control levels of the same at least two lipid analytes measured in either a first control sample from a subject that is known to be vulnerable to plaques, a second control sample that is known to be non-vulnerable to plaques, or a healthy control sample from a healthy subject.
With regards to claims 4-5, 7-12 and 16, it is noted that claims 4 and 10 in U.S. Patent no. 9,255,935 also recite that at least 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,1 4, 15 or 16 lipid analytes listed in Table 1 of the instant specification are measured in the method, and that these multiple lipid analytes comprise any of the modified or non-modified lipid analytes listed in Table 1, such as LPC 20:0, LPC 22:6, APC 32:1, APC 32:0, APC 34:2, APC 34:1, APC 34:0, APC 36:5, APC 36:4, APC 36:3, APC 36:2, APC 36:1, APC 36:0, APC 38:6, APC 38:5, APC 38:4, APC 38:3 and APC 38:2.
With regards to claims 13 and 22, it is noted that claims 5 and 11 in U.S. Patent no. 9,255,935 also recite that the levels of the lipid analytes are used in combination with one or more traditional risk factors of coronary artery disease (CAD) such as age, sex, smoker, diabetes, hypertension, etc.
With regards to claims 30-31, it is noted that the combination of claims 1 and 4, and 7 and 10 in U.S. 9,255,935 recite the steps of determining levels of at least two lipid analytes included in Table 1 in the instant specification, wherein Table 1 lists both LPC 20:0 and LPC 22:6 as being possible lipid analytes to measure in the method, in a sample obtained from a subject as a risk factor of being vulnerable with respect to plaques and with respect to heart disease as a necessary step to provide therapeutic treatment to the subject, and thus, recite the same methods recited in instant claims 30 and 31.
Response to Arguments
Applicant's arguments filed December 18, 2025 have been fully considered but they are not persuasive.
The previous rejections of the claims made under 35 USC 112, second paragraph in the last Office action mailed on June 20, 2025 have been withdrawn in view of the amendments made to the claims. However, new rejections of the amended claims under 35 USC 112, second paragraph are made above, as necessitated by the amendments made to the claims and the introduction of new claims 27-33.
The previous rejection of the claims under 35 USC 101 has been withdrawn in view of the amendments made to the claims and Applicant’s persuasive arguments. The amended claims are now similar to claim 6 in Example 29 of the USPTO’s Subject Matter Eligibility Examples where claim 6 was found patent eligible under 35 USC 101 because even though the treatment of a subject with anti-tumor necrosis factor (TNF) antibodies was “well-understood, routine and conventional” activity engaged in by doctors in the field, the combination of steps as a whole recited in claim 6 adds meaningful limits on the use of the exception. Claim 6 in Example 29 was found to be patent eligible because the recitation of a particular treatment (i.e. administration of anti-TNF antibodies) integrated the recited exception (i.e. correlation between JUL-1 in a plasma sample of a subject and julitis in the subject) into a diagnostic and treatment process, and the administration of the anti-TNF antibodies, when considered as a combination with the other additional elements, resulted in a claim as a whole that amounts to significantly more than the exception itself. In a similar way, the recitation of the treatment of the subject in the instant claims by administering a lipid-lowering medication, such as a statin, to the subject also results in a particular treatment that integrates the recited exception (i.e. the correlation between the lipid analytes LPC 20:0, LPC 22:6 and the other lipid analytes recited in Table 1 of the instant specification) into a diagnostic and treatment process. While lipid-lowering medications are “well-understood, routine and conventional” activity engaged in by doctors in the field to treat vulnerability to plaques and heart disease, when used in combination with the steps of measuring the lipid analytes LPC 20:0, LPC 22:6 and the other lipid analytes recited in Table 1 of the instant specification in a biological sample obtained from a subject to indicate whether the subject is vulnerable to plaques or to heart disease, this treatment step adds meaningful limits on the use of the exception, and thus, the claims are now patent eligible under 35 USC 101.
The amended claims are now rejected on the ground of nonstatutory double patenting as being unpatentable over claims in both U.S. Patent nos. 9,110,086 and 9,255,935 for the reasons set forth above, as necessitated by the amendments made to the claims. Applicant is requested to file proper terminal disclaimers over these patents in order to obviate these rejections.
Conclusion
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 MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 February 2, 2026