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 1-7 are pending. Claims 1-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6 April 2026.
Claim 7 is examined upon its merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is the national stage entry of PCT/CN2021/112405 filed on 13 August 2021, and claiming the benefit of foreign priority under 35 U.S.C. 119 (a)-(d) of Chinese application 202010816390.5 filed 14 August 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim 7 has an effective US filing data of 4 August 2020.
Information Disclosure Statement
Applicant is reminded that there is no IDS filed in this application.
Claim Objections
Claim 7 is objected to because of the following informalities: The claim contains abbreviated terms that are not spelled out upon their first appearance within the claims (ex. SM(d18:1/24:1(15Z)) etc.). As evidenced by the PubChem search results attached, each of the compounds listed in the claims has multiple synonyms, it would be more appropriate to claim these compounds by molecular formula - SM(d18:1/24:1(15Z)) has the molecular formula of C47H93N2O6P. Appropriate correction is required.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over PGPub US 20120202188, published on 8 September 2012, and effectively filed on 1 October 2009 (hereafter “the ‘188 publication”) taken with the Lupo and Kahler article published on the LCGC International website, 1 July 2017.
It should be noted that the “TG(16:0/18:0/18:4(6Z,9Z,12Z,15Z))” has the molecular formula of C55H98O6. The claimed PC(P- 16:0/22:4(7Z,10Z,13Z,16Z)) has the molecular formula C46H84NO7P, and the claimed PC(P- 18:0/18:4(6Z,9Z,12Z,15Z)) has the molecular formula of C44H80NO8P (See attached PubChem search reports).
Regarding claim 7, the ‘188 publication discloses methods comprising analyzing samples by LC/MS and MS/MS and discloses the elements of the instantly claimed kit:
A standard SM(d18:1/24:1(15Z)). See FIG. 39 of the ‘188 publication illustrates synthetic SM(d18:1/24:1(15Z)) (from Avanti Polar Lipids, cat. 860593).
The prior art further teaches the elements of PC(P- 16:0/22:4(7Z,10Z,13Z,16Z)) having the molecular formula C46H84NO7P; and PC(P- l 8:0/18:4(6Z,9Z,12Z.15Z)), [C44H80NO8P] (See Table 4).
The prior art further teaches solutions comprising 1% ammonium hydroxide to which 0.33% formic acid was added for sample extraction. It is well-understood in Chemistry that mixing ammonium hydroxide (NH4OH) and formic acid (HCOOH) results in a neutralization reaction that produces ammonium formate (NH4HCOO) or (HCOONH4) and water (H2O). This teaches the “ammonium formate as solute” of the instant claim.
The prior art further teaches the combination of isopropanol:methanol:formic acid (Section 4.1).
For Aqueous extracts the prior art teaches (see Section 4.2) there are two additional solvents. Solvent A: H 2O-MeOH-formic acid (94.9:5:0.1, v/v/v) and solvent B: MeOH-formic acid (99.9:0.1, v/v).
The Lupo and Kahler prior art article teaches different buffers may be used in LC/MS methods. In particular, while the ‘188 Publication uses isopropanol in combination with methanol, the Lupo and Kahler prior art teaches, “In general, ammonium salts are the most soluble and sodium salts are the least, while methanol tends to exhibit greater solubility than acetonitrile does” (text paragraph following Figure 2). This renders obvious the isopropyl alcohol and acetonitrile as solvent of the instant claims, since acetonitrile of the claims can be used interchangeably for the methanol (MeOH) of the ‘188 prior art.
Furthermore, while the prior art solutions may differ from the instant claims in terms of concentrations and volume ratios, the Courts have stated that, generally, such differences amount to mere optimization and will not support patentability unless there is evidence indicating the claimed feature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). In KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421.
Thus, while elements of the solvent solutions are disclosed in the prior art of record, the concentrations may differ from those of the instant claims. A person having ordinary skill in the LC/MS technological field, would have been able to alter the concentrations through routine experimentation to arrive at the “10 mM ammonium formate”, “0.1% formic acid”, “volume ratio of 60:40” or “volume ratio of 90:10” of the instant claims.
Lastly, while the ‘188 prior art teaches the elements of the kit are used for detecting diseases and physiological conditions the particular focus is pancreatic cancer, the court in Merck KGaA v. Integra LifeSciences Ltd, 50 USPQ2d 1846 (DC SCalif, 1999) held that a reference comprising the same steps/elements serves as prior art, despite the recitation of a different intended use in the preamble or the later discover of a particular property of the material used.
For all these reasons, the invention of Claim 7 is obvious in view of what was disclosed in the art prior to filing and what could have been achieved through routine experimentation.
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 7 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of copending Application No. 18021229 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the elements of the claim recite SM(d17:1/24:1) as a standard and liquids A and B are identical to those of the instant claims. While the instant claims require at least one additional element selected from TG(16:0/18:0/18:4(6Z,9Z,12Z,15Z)); PC(P- 16:0/22:4(7Z,10Z,13Z,16Z)); or, PC(P- 18:0/18:4(6Z,9Z,12Z,15Z)), claim 5 of the reference application has open-ended language (“comprising”) and does not specifically exclude additional elements. Further, while the intended use of the reference claim is “diagnosing acting of nervonic acid”, however, with respect to a product invention, MPEP 2111.02 states: “Any terminology in the preamble that limits the structure of the claimed invention must be treated as a claim limitation.” This recitation imposes no structure upon the scope of the kit invention and therefore is not limiting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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, Jeffrey Stucker can be reached at 571-272-0911. 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.
/STACEY N MACFARLANE/Examiner, Art Unit 1675
Prosecution Insights