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 .
Election/Restrictions
Claims 312-314 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/3/2025.
Claim Objections
Claims 309-311 are objected to because of the following informalities: in each of the independent claims, the first instance of the abbreviations “COPD” and “LPA” should be provided in parenthesis, with the full word or phrase associated with it; for example, “chronic obstructive pulmonary disease (COPD)” and “lysophosphatidic acid (LPA)”. Appropriate correction is required.
Claim Interpretation
The claimed “reference level” is defined in the instant specification. As such, reference to this term is not considered indefinite.
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 309 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.
Claim 309 is indefinite because it is unclear how the level of lysophosphatidic acid (LPA) in the sample relates to the method of treating chronic obstructive pulmonary disorder (COPD) exacerbations. First, the ordinary artisan would understand that there are well-known and routine methods of treating/reducing COPD exacerbations, and as such, this portion of the claim is clear. See Evensen (American Family Physician, 81, 607-613, 2010), page 610, Table 5. However, it is unclear at what point the level of LPA is determined, and how its concentration, with respect to a reference level, relates to the claimed method of treating/reducing COPD exacerbations. It is unclear if this level is meant to inform the artisan who would be considered within the viable subject-pool, or if this level is meant to inform the artisan as to how a treatment dosage should be modified following the administration of a treatment.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 310 and 311 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a method of monitoring a response. This judicial exception is not integrated into a practical application because the claims are drawn to observations and mental steps, without providing for any practical application of the acquired data. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are drawn to a measuring step, that is considered routine and convention, and a comparing step, which is considered a mental process.
Both claims 310 and 311 are drawn to an abstract idea because the steps do not result in a practical application of the acquired data; for example, if the comparing step informs the artisan how to modify a treatment regimen, and provides claim limitations that allow for this application, the claims would likely be in compliance of 35 USC 101. See MPEP2106.04(a).
The claims can be broken into two steps: the first step provides for a measuring step, and the second step provides for a mental step. Based upon the above-cited section of the MPEP, the second step is considered a mental step, wherein the only way the claim could be eligible is if a practical application is claimed, or if the measuring step can be considered non-routine. Following a search of the prior art, it was found that measuring various forms of LPA is already known in the art, and as such, can be considered well-understood, routine and conventional. See MPEP 2106.05(d); Toews, et al (Biochimica et Biophysica Acta, 1582, 240-250, 2002); Ackerman, et al (Biomarkers in Medicine, 10, 123-135, 2016). Based upon the prior art, the only thing that the Applicant has discovered is the claimed reference points for these molecules; however, since the claims do not provide direction for what must be done when the artisan is above or below the reference point, there is no practical application of the comparison step. See MPEP 2106.04(d). As such, these claims are considered ineligible under 35 USC 101.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 309 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Evensen (American Family Physician, 81, 607-613, 2010). Evensen teaches methods of treating/reducing COPD exacerbations. See page 610, Table 5. Although Evensen does not teach anything about LPA levels, the limitation following the administration of the drug does not appear to be a method step, but rather describes an inherent behavior of either pre- or post-administration physiology. See the 35 USC 112(b) rejection, above.
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.
Claim 309 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 8-10, 23, 25, 27, 28, 30, 33, 36, 40-54, 56, 76, and 84-103 of copending Application No. 18/528,122 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because, even though the copending Application does not claim anything about LPA levels, the limitation following the administration of the drug does not appear to be a method step, but rather describes an inherent behavior of either pre- or post-administration physiology. See the 35 USC 112(b) rejection, above. Since both the instant claim and the copending claims are directly drawn to methods of treating COPD and related exacerbations, they inventions read upon each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651