The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-11 are presented for examination.
Acknowledgement is made of the present application as a National Stage (371) entry of PCT Application No. PCT/ES2019/070565, filed August 12, 2019, which claims benefit under 35 U.S.C. §119(a-d) to Spanish Patent Application Nos. ESP201830824, filed August 10, 2018, and ESP201830825, filed August 10, 2018. Receipt is acknowledged of a certified copy of each of the ‘824 and ‘825 applications in the instant application on February 9, 2021, as required by 37 C.F.R. §1.55.
Requirement for Restriction/Election
Applicant’s election without traverse of (i) a compound that is both a PPARa agonist and a CB1 receptor antagonist, and (ii) the single disclosed species of N-[1-(3,4-dihydroxyphenyl)propan-2-yl]oleamide (CAS Registry No. 1258011-97-0), also known as OLHHA, which has the chemical structure
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, to which examination on the merits will be confined, as stated in the reply filed August 22, 2025, is acknowledged by the Examiner.
In the remarks filed August 22, 2025, Applicant contends that “the Alen et al. reference relied upon by the Examiner in the Restriction Requirement is not available as prior art, and therefore, not relevant to [u]nity of [i]nvention or any future determination of patentability” (Remarks, p.5). Applicant argues that “Alen et al. was published online September 6, 2018, which is after the earliest priority date of August 10, 2018 for the present application” (Remarks, p.5). Applicant states that “[e]ven assuming the present claims are not entitled to the application’s earliest priority date (which Applicant submits is not the case), Alen et al. is excluded as prior art under 35 U.S.C. §102(b)(1)(A) as being made by the inventor or joint inventor” (Remarks, p.6).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant asserts that the instant claims under examination are entitled to the benefit of the earlier priority date of August 10, 2018, but this is incorrect. The previously filed Spanish Patent Applications ESP 201830824 and ESP 201830825, each filed on August 10, 2018, were filed in Spanish – not in English – and a certified English translation of the application(s) has not been filed for evaluation. As a result, Applicant’s claims presently under examination are not entitled to this earlier effective filing date of August 10, 2018. The earliest effective filing date properly afforded to the claims at present is August 12, 2019, the filing date of PCT Application No. PCT/ES2019/070565 (of which the instant application is a National Stage (371) entry).
Because the effective filing date of the instant claims presently under examination is August 12, 2019, the Alen et al. publication of September 6, 2018 relied upon in the Requirement for Restriction/Election remains properly applied prior art under AIA 35 U.S.C. §102(a)(1).
Applicant contends that – even if Alen et al. were properly applied prior art - the publication constitutes a prior art exception under AIA 35 U.S.C. §102(b)(1)(A) by stating that the Alen et al. publication was “made by the inventor or joint inventor”. This is unavailing. MPEP §2153.01(a) governs grace period inventor-originated disclosure exceptions under AIA 35 U.S.C. §102(b)(1)(A), stating that “a disclosure that would otherwise qualify as prior art under AIA 35 U.S.C. 102(a)(1) may not be used as prior art by Office personnel if the disclosure is made one year or less before the effective filing date of the claimed invention, and the evidence shows that the disclosure is an inventor-originated disclosure”. MPEP §2153.01(a) goes on to state, “In order to be effective to show that a grace period inventor-originated public disclosure is not prior art under AIA 35 U.S.C. 102(a)(1) because the AIA 35 U.S.C. 102(b)(1)(A) exception applies, the statement must convey the same information as would be required in a declaration under 37 CFR 1.130(a)”, citing to MPEP §717.01(a)(1), §2155.01 and §2155.03 for additional explanation.
MPEP §2155.01 provides further guidance, stating that “AIA 35 U.S.C. 102(b)(1)(A) provides that a grace period disclosure shall not be prior art to a claimed invention under AIA 35 U.S.C. 102(a)(1) if the disclosure was made by the inventor or a joint inventor. An applicant may show that a disclosure was made by the inventor or a joint inventor by way of an affidavit or declaration under 37 CFR 1.130(a) (an affidavit or declaration of attribution). See In re Katz, 687 F.2d 450, 455, 215 USPQ 14, 18 (CCPA 1982) and MPEP §717.01(a)(1). Where the authorship of the prior art disclosure includes the inventor or joint inventor that the inventor or joint inventor (or some combination of named inventors) invented the subject matter of the disclosure, accompanied by a reasonable explanation of the presence of additional authors, may be acceptable in the absence of evidence to the contrary. See In re DeBaun, 687 F.2d 459, 463, 214 USPQ 933, 936 (CCPA 1982).”
Here, the Alen et al. publication was authored by Francisco Alen, Juan Decara, Gloria Brunori, Zhi-Bing You, Kora-Mareen Buhler, Jose Antonio Lopez-Moreno, Andrea Cippitelli, Francisco Javier Pavon, Juan Suarez, Eliot Gardner, Rafael de la Torre, Roberto Ciccocioppo, Antonia Serrano, and Fernando Rodriguez de Fonseca – of which only Alen, Decara, Serrano and Rodriguez de Fonseca are named as inventors of the instant application. Applicant fails to provide any reasonable explanation of the presence of the additional authors in an affidavit or declaration under 37 C.F.R. §1.130(a), as required by MPEP §2155.01. Instead, Applicant proffers only a conclusory statement in the remarks filed in reply to the outstanding restriction requirement that the Alen et al. publication was “made by the inventor or joint inventor” and, thus, should be treated as a prior art exception under AIA 35 U.S.C. §102(b)(1)(A), but such statement fails to satisfy the showing required under MPEP §2155.01 to establish that Alen et al. constitutes a grace period inventor-originated disclosure exception.
As a result, Alen et al. remains available prior art to the instant claims, as it was published online September 6, 2018, which is before Applicant’s earliest effective filing date of August 12, 2019 (see below, under the heading “Priority” for further explanation) and further considering Applicant’s failure to persuasively establish Alen et al. as a prior art exception under AIA 35 U.S.C. §102(b)(1)(A).
Therefore, for the reasons above and those made of record at p.2-7 of the Office Action dated February 25, 2025, the requirement remains proper and is hereby made FINAL.
Claims 2-3, 5-7 and 9 are withdrawn from consideration pursuant to 37 C.F.R. §1.142(b) as being directed to non-elected subject matter.
The claims that are drawn to the elected species are claims 1, 4, 8 and 10-11 and such claims are herein acted on the merits infra.
Priority
Acknowledgement is made of the present application as a National Stage (371) entry of PCT Application No. PCT/ES2019/070565, filed August 12, 2019, which claims benefit under 35 U.S.C. §119(a-d) to Spanish Patent Application Nos. ESP 201830824, filed August 10, 2018, and ESP 201830825, filed August 10, 2018. The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original non-provisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. §112(a) or the first paragraph of pre-AIA 35 U.S.C. §112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
As Applicant’s prior-filed ‘824 or ‘825 Spanish patent applications to which he claims benefit are not filed in English, and a certified English translation of the same has not been provided in the record, these earlier-filed ‘824 or ‘825 applications cannot be fully evaluated to determine sufficiency of support for the claimed subject matter. As a result, Applicant’s claims presently under examination are not afforded the benefit of the earlier filing date of the ‘824 or ‘825 foreign applications.
Accordingly, the effective filing date of claims 1, 4, 8 and 10-11 is August 12, 2019 (the filing date of the ‘565 PCT application).
The Examiner will revisit the issue of priority as necessary each time the claims are amended.
Objection to the Claims
Claim 1 is objected to for failing to define the acronyms “PPAR” and “CB” at their first occurrence in the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) (Pre-AIA Second Paragraph)
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.
(1) Claim 8 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.
Applicant’s claim 8 defines the compound of claim 4 as “N-[1-(3,4-dihydroxyphenyl)propan-2-yl]oleamide (OLHHA), or any pharmaceutically acceptable salts thereof”.
It is unclear if Applicant intends to define the PPARa agonist and CB1 receptor antagonist compound of claim 4 as OLHHA or multiple “pharmaceutically acceptable salts thereof” (as implied by the plural form of “salts”), or whether he intends to define the compound as OLHHA or a single pharmaceutically acceptable salt thereof. Clarification is required.
For these reasons, the claim fails to meet the tenor and express requirements of 35 U.S.C. §112(b) (pre-AIA second paragraph) and is, thus, properly rejected.
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.
(2) Claims 1, 4, 8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alen et al. (“PPARa/CB1 Receptor Dual Ligands as a Novel Therapy for Alcohol Use Disorder: Evaluation of a Novel Oleic Acid Conjugate in Preclinical Rat Models”, Biochemical Pharmacology, 2018; 157:235-243, Published Online September 6, 2018, cited on the 02/25/25 PTO-892).
Alen et al. teaches an experimental study of N-[1-(3,4-dihydroxyphenyl)propan-2-yl]oleamide (OLHHA), a dual PPARa agonist/CB1 receptor antagonist, and (R)-3-[(4-benzyl-2-oxooxazolidin-3-yl)methyl]-N-[4-dodecylcarbamoyl)phenyl]benzamide (NF 10-360), a dual PPARa/g agonist, in an animal model of alcohol consumption (abstract). Alen et al. uses adult male Wistar rats or male genetically selected alcohol-preferring Marchigian Sardinian (msP) rats for the experimental study, and further teaches that the tested compounds were administered as a solution for injection by dissolving the compound in vehicle solution (1% TWEEN 80 in 0.9% saline) (col.1, para.5, p.236-col.2, para.1, p.236; col.2, para.3, p.236). Alen et al. teaches that the effects of the dual PPARa agonist/CB1 receptor antagonist OLHHA were studied in ethanol self-administration in adult male Wistar rats, and observed that OLHHA dose-dependently reduced alcohol consumption to 7% of that exhibited by control animals when administered at a maximal dose of 5 mg/kg (col.1, para.3, p.241). Alen et al. also administered 5 mg/kg OLHHA to alcohol preferring msP rats to analyze alcohol consumption at 2, 8 and 24 h after its administration, noting that OLHHA reduced alcohol consumption at 2 h (60% reduction in alcohol intake as compared to control) and 8 h (30% reduction in alcohol intake as compared to control) post-injection, but that the effect almost disappeared after 24 h, suggesting that the pharmacological effects are time-limited (col.1, para.4, p.241; col.1, para.3, p.242). Alen et al. observed that total alcohol intake reported after OLHHA treatment was significantly decreased in the tested animals, indicating a long-term reduction of alcohol intake due to daily OLHHA treatment when ethanol is continuously made available (col.1, para.4, p.241). Alen et al. states that OLHHA, a dual PPARa agonist/CB1 receptor antagonist, reduces alcohol self-administration and voluntary alcohol consumption in preclinical models of alcohol use disorder without inducing tolerance, or liver or inflammatory parameters indicative of toxicity (col.2, para.2, p.242).
Claim 1 recites “[a] method for preventing, alleviating, improving and/or treating alcohol use disorder in a subject in need thereof” via administering, inter alia, a compound that is a PPARa agonist and CB1 receptor antagonist.
Claim 4 limits the compound to one that exhibits both PPARa agonist and CB1 receptor antagonist activity.
Claim 8 depends from claim 4 and defines the compound as OLHHA.
Claim 10 teaches that the method is for preventing, alleviating and/or treating alcohol use disorder.
Here, Alen et al. clearly teaches the administration of the dual PPARa agonist/CB1 receptor antagonist OLHHA to a preclinical animal model of alcohol use disorder (male Wistar rats that self-administer alcohol, or the alcohol preferring msP rats) and observed a significant reduction in total alcohol intake following OLHHA treatment, thereby meeting Applicant’s instantly claimed method directed to “preventing, alleviating, improving and/or treating alcohol use disorder in a subject in need thereof” as recited in claim 1 (or more narrowly in claim 10) by administering the dual PPARa agonist/CB1 receptor antagonist OLHHA.
Therefore, instant claims 1, 4, 8 and 10 are properly anticipated under AIA 35 U.S.C. §102(a)(1).
(3) Claims 1, 4, 8 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rodriguez de Fonseca (WO 2016/083646 A1; 2016), citing to U.S. Patent No. 11,058,650 B2 as an English translation of the same1.
Rodriguez de Fonseca et al. teaches compounds of formula (I), which has the structure
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, in which X and Y can independently be the same or different and are selected from hydrogen, halogen and methyl; n is an integer from 1 and 4; R1 and R2 are each independently the same or different and are hydrogen and C1-C6 alkyl, or can be bound by a single bond between the two oxygen atoms forming a new ring; R3 is selected from hydrogen, C1-C6 alkyl and C1-C4 alkenyl; R4 is selected from hydrogen, halogen and C1-C4 alkyl; and R5 is a compound of the general formula
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, in which R6 is selected from C1-C4 alkyl and R7 is selected from C8-C30 alkyl and C8-C30 alkenyl for use in the treatment of fatty liver or a pathological condition or disease caused by fatty liver (col.2, l.47-col.3, l.23). Rodriguez de Fonseca et al. teaches that the compound of formula (I) is, preferably, the compound N-(1-(3,4-dihydroxyphenyl)propan-2-yl)oleamide, also known as OLHHA, which has the chemical structure
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(col.5, l.44-55; col.11, l.31-42). Rodriguez de Fonseca et al. teaches that the compound may be formulated as a pharmaceutical or food composition particularly wherein the composition is for use in the prevention, relief or treatment of a disease caused by alcoholic fatty liver disease, preferably alcoholic steatohepatitis (col.5, l.56-col.6, l.6; col.6, l.16-20; col.6, l.27-35; col.6, l.41-45; col.12, l.57-61; col.15, l.16-20). Rodriguez de Fonseca et al. further teaches a method for the prevention, relief or treatment of a subject, preferably a human, suffering from alcoholic fatty liver disease or alcoholic steatohepatitis comprising administering the pharmaceutical composition or food composition of the at least one compound of formula (I) to the subject (col.6, l.46-54). Rodriguez de Fonseca et al. defines alcoholic steatohepatitis as being triggered from abusive alcohol consumption (col.1, l.25-28).
Claim 1 recites “[a] method for preventing, alleviating, improving and/or treating alcohol use disorder in a subject in need thereof” via administering, inter alia, a compound that is a PPARa agonist and CB1 receptor antagonist.
Claim 4 limits the compound to one that exhibits both PPARa agonist and CB1 receptor antagonist activity.
Claim 8 depends from claim 4 and defines the compound as OLHHA.
Claim 10 teaches that the method is for preventing, alleviating and/or treating alcohol use disorder.
Claims 11 teaches that the method is for preventing, alleviating and/or treating alcohol use disorder and that the composition is a food composition.
The teachings of Rodriguez de Fonseca et al. provide for the administration of a pharmaceutical or food composition comprising a compound of formula (I) (of which the specific compound OLHHA is the preferred embodiment thereof) to a subject (preferably a human) that is suffering from alcoholic steatohepatitis for prevention, relief or treatment of the same.
As Rodriguez de Fonseca et al. clearly teaches that abusive alcohol consumption is the cause of alcoholic steatohepatitis, the subject (preferably human subject) that suffers from alcoholic steatohepatitis described by Rodriguez de Fonseca et al. must necessarily exhibit abusive alcohol consumption and, thus, meets Applicant’s requirement that the subject be “in need” of “preventing, alleviating, improving and/or treating alcohol use disorder” as recited in claim 1.
The effect to prevent, relieve or treat alcoholic steatohepatitis as a manifestation of alcohol use disorder as described by Rodriguez de Fonseca et al. also meets Applicant’s recited therapeutic objective of “preventing, alleviating, improving and/or treating alcohol use disorder” of claim 1 by treating a specific manifestation of the abusive alcohol consumption.
Any specific therapeutic effect that the administration of such compound has in “preventing, alleviating, improving and/or treating alcohol use disorder” in the subject must necessarily also yield from Rodriguez de Fonseca’s teachings, as the prior art teachings provide for executing an identical method step as claimed in an identical patient population such that whatever specific effects such administration has on alcohol use disorder per se must also result because products of identical chemical composition cannot have mutually exclusive properties, particularly when used in an identical manner. MPEP §2112.
Therefore, instant claims 1, 4, 8 and 10-11 are properly anticipated under AIA 35 U.S.C. §102(a)(1).
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.
(4) Claims 1, 4, 8 and 10-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,058,650 B2.
Claim 1 of the ‘650 patent recites a method for relief or treatment of steatohepatitis comprising administering to a subject in need thereof a composition comprising the compound OLHHA, or a pharmaceutically acceptable salt, ester, tautomer, solvate or hydrate thereof.
Claims 2-3 of the ‘650 patent define the steatohepatitis as non-alcoholic fatty liver disease or non-alcoholic steatohepatitis.
Claim 4 of the ‘650 patent recites that the composition further comprises a pharmaceutically acceptable vehicle.
Claim 5 of the ‘650 patent defines the composition as a food, nutraceutical or medical food-type composition.
Claims 6-14 of the ‘650 patent define effects of the administration of OLHHA, including reducing hepatic total fat in the subject (claim 6), reducing serum triglycerides and lipid accumulation in the liver of the subject (claim 7), reducing gene expression of lipogenic enzymes in the subject (claims 8-9), reducing transaminase levels in the subject (claims 10-11), reducing pro-inflammatory cytokines in the subject (claims 12-13) and reducing apoptosis in the liver of the subject (claim 14).
In claims 1 and 4, Applicant recites “[a] method for preventing, alleviating, improving, and/or treating alcohol use disorder in a subject in need thereof” by administering a compound that is a PPARa agonist and CB1 receptor antagonist, which is further defined in claim 8 as the compound OLHHA.
Such effect to “prevent” alcohol use disorder “in a subject in need thereof” as provided for in claim 1 (as well as claims 10-11) must necessarily yield from the ‘650 patent claims because the ‘650 patent claims provide for the administration of an identical compound (in this case, OLHHA) to an identical subject, since any subject – including those subjects of the ‘650 patent claims – is reasonably in need of prevention of alcohol use disorder. An identical product must exhibit the same properties (in this case, prevention of alcohol use disorder) when used in an identical manner in an identical subject. MPEP §2112.01(II). A chemical composition and its properties are inseparable – especially when used in an identical way.
MPEP §2112 states that, “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).” There is no requirement that a person of ordinary skill in the art would have recognized the newly cited function and/or property at the time of invention, as long as the function and/or property is reasonably expected to be present. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment … is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention”).
In claim 11, Applicant provides for the composition to be “a food composition”.
The ‘650 patent claims provide for the OLHHA to be in the form of a food, nutraceutical or medical food composition, thereby meeting the limitations of Applicant’s claim 11.
This is a non-provisional nonstatutory double patenting rejection.
Conclusion
Rejection of claims 1, 4, 8 and 10-11 is proper.
Claims 2-3, 5-7 and 9 are withdrawn from consideration pursuant to 37 C.F.R. 1.142(b).
No claims of the present application are allowed.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Leslie A Royds Draper whose telephone number is (571)272-6096. The examiner can normally be reached Tuesday to Thursday (08:30 AM to 05:00 PM).
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 S. Lundgren can be reached at (571)-272-5541. 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.
/Leslie A. Royds Draper/Primary Examiner, Art Unit 1629
September 17, 2025
1 U.S. Patent No. 11,058,650 B2 will be relied upon for an English translation of the WO 2016/083646 A1 reference used as the basis for the present rejection. The ‘650 patent directly resulted from the filing of U.S. Patent Application No. 15/529,433, which was the U.S. National Stage (371) entry of PCT Application No. PCT/ES2015/070848, of which WO 2016/083646 A1 is the International WIPO publication of the same and is, thus, expected to contain the same subject matter. Reliance upon this document is in accordance with MPEP §901.05, which states, “It is possible to cite a foreign language specification as a reference, while at the same time citing an English language version of the specification with a later date as a convenient translation if the latter is in fact a translation”. Column and line numbers cited herein the instant rejection refer to the ‘650 English language patent and not the ‘646 WIPO publication.