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 .
Reissue Applications
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions. This application, filed May 31, 2024, is a reissue continuation of U.S. application Serial No. 17/359,639, now RE50,049, which is a reissue of U.S. Patent 9,636,321 (hereafter the '321 patent), which issued from U.S. application Serial No. 15/081,898 (the ‘898 application) with claims 1-21 on May 2, 2017.
Priority
The domestic benefit information in the Application Data Sheet (ADS) filed with the application on 05/21/2024 does not state that the 15/081,898 claims the benefit of provisional application 62/139,619. Rather, it states that the present reissue application claims the benefit of the provisional application:
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The corrected ADS filed 06/21/2024 changed the application number pointed to by the above annotation arrow to “15081898” without listing the change in the “Updated Data” column of the corrected ADS. This is improper since the ADS filed 05/21/2024 did not make such a priority claim.
Furthermore, even though the current filing receipt states that 15/081,898 claims the benefit of provisional application 62/139,619, Applicant must file a petition for delayed priority claim under 37 CFR 1.78 with appropriate fee to make the change because a direct priority claim between the current reissue application and the provisional application, as set forth in the ADS filed with the reissue application on 05/21/2024, is not possible. In accordance with MPEP 211.02(a).II, “[a]ny petition under 37 CFR 1.78 must be accompanied by a corrected ADS in compliance with 37 CFR 1.76(c) (for applications filed on or after September 16, 2012).”
While the Director may require additional information whenever there is a question of whether the delay was unintentional, a person filing a petition to accept a delayed benefit claim more than two years after the date the benefit claim was due is required to provide additional explanation, i.e., in the petition, of the circumstances surrounding the delay that establishes that the entire delay was unintentional. This requirement is in addition to the requirement to provide a statement that the entire delay was unintentional in 37 CFR 1.78(c)(3) and (e)(3). See Clarification of the Practice for Requiring Additional Information in Petitions Filed in Patent Applications and Patents Based on Unintentional Delay, 85 FR 12222-24 (March 2, 2020). See also MPEP § 711.03(c) for further discussion of the "unintentional" delay standard.
Also, the corrected ADS filed 06/21/2024 improperly lists the following data as if it was present in the original ADS filed 05/21/2024:
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This data is newly added to the original ADS and must be presented as underlined in the “Updated Data” column of a corrected ADS. This is so regardless of what is stated in the filing receipt.
In view of all of the above, the request for corrected filing receipt filed 06/21/2024 will not be processed. Applicant is reminded that any changes in a corrected ADS must be made with respect to the ADS filed 05/31/2024.
Claims Under Reissue
During patent examination, the pending claims must be given their broadest reasonable interpretation consistent with the specification. In re Reuter, 651 F.2d 751, USPQ 249 (CCPA 1981) (claims given "their broadest reasonable interpretation consistent with specification"). This reissue application contains claims 22-28 directed to a compound. Claims 22 and 28, as presented in amendment of 05/31/2024, are independent and representative.
Claim 22. (New) A compound according to general formula (I):
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in which R1 and R2 are both -CH=CH-COOMe or one of R1 and R2 is H and the other -CH=CH-COOMe; provided that when R1 and R2 are the same, the -CH=CH-COOMe groups are fumarate groups.
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Reissue Declaration and 35 USC 251
The reissue oath/declaration filed with this application is defective (see 37 CFR 1.175 and MPEP § 1414) because of the following:
The error statement in the reissue declaration reads as follows: “The structure for formula (I) is incorrect and claim 1 is to [sic] broad as issued.”
This error statement is unacceptable because it fails to point out the error in the structure of formula (I) or the specific language in claim 1 that makes claim 1 too broad. To the extent that the structure of formula (I) is “incorrect” due to the location of the R2-C(O)- group on the left side of the formula, movement of the R2-C(O)- to its proper location is an obvious error that would not support a reissue application.
A new declaration with a proper error statement is required.
Claims 22-28 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the reissue declaration is set forth in the discussion above in this Office action.
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 22, 23 and 25-28 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 22 recites the broad recitation (emphasis added) “provided that when R1 and R2 are the same, the -CH=CH-COOMe groups are fumarate groups”. “Fumarate groups” encompass any fumarate ester, not just the methyl ester. Claim 22 also recites “in which R1 and R2 are both -CH=CH-COOMe” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The same applies to dependent claims 23 and 25-27.
With respect to claim 28, the ‘321 patent specification states at col. 9, lines 40-54: “isosorbide di-(methyl fumarate) (IMDF) whose structure (IV) is given below:
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.”
Structure (IV) has different stereochemistry from the “isosorbide di-(methylfumarate)” compound presented in claim 28:
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.
In view of this consistency with the specification, claim 28 is indefinite.
Claim 28 is also indefinite because it is unclear whether the two wedges noted below by annotation arrows are intended to be methyl groups or hydrogens. Such wedges are normally considered to be methyl groups if nothing is attached and the end of the wedge.
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.
However, the compound in claim 28 was present in the original specification filed 03/27/2016 (¶ 0065, p. 13) of the ‘898 application as compound “(IV)”. In an amendment to the specification filed 02/09/2017, Applicant replaced said compound in claim 28 with compound (IV) present at col. 9, lines 45-54 of the ‘321 patent specification, reproduced below:
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In so doing, Applicant stated the following in the accompanying Remarks filed 02/09/2017 (p. 7):
Amendment to the Specification
Applicant has replaced the prior Structure (IV) with the new Structure (IV) presented above. As originally proposed, Applicant had overlooked the fact that the dark wedges off the fused ring carbon atoms are typically understood to represent methyl groups in the absence of any indication otherwise. However, those skilled in the art will readily recognize and appreciate that the presence of methyl groups at these positions in this structure is not possible as the structure would no longer be embraced by Structure (I) and, any event, does not correspond to the named structure presented. Indeed, a process for the production of this compound, IMDF, is presented in Example 1. Again, those skilled in the art will readily recognize and appreciated [sic] that the process described in Example I does not and cannot result in compounds of Structure (IV) wherein methyl groups are present at the carbon atoms of the fused ring. Accordingly, it is respectfully requested that the amendment be admitted.
Due to uncertainty as to whether the above noted wedges are methyl groups or hydrogen atoms, claim 28 will be examined as if either are present.
Claim Rejections - 35 USC § 251
Claims 22, 23 and 25-28 are rejected under 35 U.S.C. 251 as being broadened in a reissue application filed outside the two year statutory period.
In claim 22, the recitation “provided that when R1 and R2 are the same, the -CH=CH-COOMe groups are fumarate groups” broadens the scope of issued claim 1. The “fumarate groups” encompass practically any ester of fumaric acid. Issued claim 1 is narrower and requires that, when R1 and R2 are the same, they are both -CH=CH-COOMe. Said recitation should be deleted from claim 22. The same applies to dependent claims 23 and 25-27.
Claim 28 is broader than claim 1 when either or both of the wedges noted below with annotations arrows in the compound of claim 28 are a methyl group rather than a hydrogen atom. The corresponding positions in the compound of claim 1 are each hydrogen atoms, not methyl groups.
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Applicant is reminded that all claims in the present reissue application must be either the same scope as, or narrower in scope than, claim 1 of the ‘321 patent.
A claim is broader in scope than the original claims if it contains within its scope any conceivable product or process which would not have infringed the original patent. A claim is broadened if it is broader in any one respect even though it may be narrower in other respects.
Claim Rejections - 35 USC § 102 and 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.
(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.
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.
Claims 22, 23 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zenner et al, “Unexpected Tackifiers from Isosorbide,” ChemSusChem, vol. 8, issue 3 pp. 448-451, first published 19 January 2015 (hereinafter “Zenner”)1.
Zenner teaches the following compound No. 12 (see p. 450, Fig. 4):
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which reads on the instant compound of general formula (I) wherein R1 and R2 are the same and are -CH=CH-COOMe.
Claims 22, 23 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2015/0274861 to Chen et al (hereinafter “Chen”).
Chen teaches tackifier compounds (see Abstract and ¶¶ 0003-0004). In ¶ 0055 (p. 9), Chen’s tackifier compound can be chosen from
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,
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and
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Chen also teaches tackifiers compounds that can form a cured tackifier or polymer (see ¶ 0071). Examples of the tackifier compound are in ¶ 0074 and include the following compounds on pp. 16, 17 and 18:
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,
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and
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.
With respect to R2 in each of the above compounds, Chen teaches that “[i]n some embodiments, R2 can be -OH. In some embodiments, R2 can be -OR3. At each occurrence R3 can be independently chosen from (C1-C10)alkanyl, (C2-C10)alkenyl, (C2-C10)alkynyl, C5-C20(aryl), and (C1-C20)heteroaryl, wherein R3 is unsubstituted or substituted with at least one J.” (See ¶ 0049). In claim 92 (p. 53), Chen more specifically teaches that R2 is -O(C1-C5)alkyl or -OH. Furthermore, Chen exemplifies the following compound where each R2 is -OMe:
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.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have prepared the compounds noted above in Chen’s ¶¶ 0055 and 0074 such that each R2 in the compounds is -OMe because Chen specifically teaches that R2 can be -O(C1-C5)alkyl and exemplifies a compound where each R2 is -OMe, and thus, so as to prepare tackifier compounds, or tackifier compounds suitable for curing/polymerization, within the scope of Chen’s disclosure.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Zenner in combination with Chen.
Zenner teaches the following compound No. 12 as an isosorbide tackifier compound (see pp. 448 and 450; and Fig. 4):
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Compound No. 12 differs from the claimed compound in that it is a stereoisomer of the claimed compound. In particular, the following is the compound in claim 28 rotated 180° along an axis perpendicular to the page:
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In Zenner’s compound No. 12, the two hydrogens noted below with annotations arrows are into, rather than out of the plane:
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Chen teaches tackifier compounds (see Abstract and ¶¶ 0003-0004). In fact, Zenner’s tackifier compound No. 12 is within the scope of Chen’s tackifier compound having the general formula in Chen’s ¶ 0003, in particular the compound having the following formula in Chen’s ¶ 0052 (see also ¶¶ 0003, 0048, 0049 and claim 92 of Chen for definitions of R’ and R2):
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Note that the squiggly lines in Chen’s formula denote that the hydrogens can be into or out of the plane.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zenner’s compound No. 12 so as to have the two hydrogens noted above out of the plane rather than into the plane because Chen teaches that the stereochemistry of the hydrogens can be into or out of the plane, and the resulting expectation of success in preparing a tackifier compound within the scope of Chen’s disclosure.
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 22-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-25 of U.S. Patent No. RE50,049 (the ‘049 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Claims 4-6 and 22 of the ‘049 patent, reproduced below, set forth a pharmaceutical composition containing the claimed compound of formula (I).
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Accordingly, instant claims 22-25 and 28 are anticipated by claims 4-6 and 22 of the ‘049 patent.
With respect to instant claims 26 and 27, claims 4-6 of the ‘049 patent differ from those here claimed since the compound of formula (I) in claims 4-6 of the ‘049 patent does not specify the orientation of the dianhydrohexitol in the compound, whereas claims 26 and 27 set forth that the compound is an isomanide or an isoidide, respectively.
However, the ‘049 patent specification teaches that “[i]t is to be appreciated that in the above formula (I), the structural orientation of the —OCOR1 and —OCOR2 groups may be in an endo orientation (an isomanide), an exo orientation (an isoidide) or one may be endo and the other exo (an isosorbide).” (See col. 9, lines 37-42). Similarly, the isosorbide, isomanide and isoidide structures are shown at col. 10, lines 10-37.
Since the instantly claimed isomanide and isoidide are taught within the disclosure of the ‘049 patent, it would have been obvious for a person of ordinary skill in the art to select the instantly claimed isomanide and isoidide to practice the compound genus in the claims of the ‘049 patent. One of ordinary skill in the art would understand that the instantly claimed compounds are within the scope of the generic compounds claimed in the ‘049 patent. Accordingly, claims 26 and 27 are rendered obvious by the claims of the ‘049 patent.
Response to Arguments
Applicant's arguments filed May 31, 2024, to the extent they apply to the above rejections, have been fully considered but they are not persuasive.
Applicant presents the “Declaration of Ratan H. Chaudhuri” (hereinafter “Chadhuri Declaration”) for the proposition of unexpected results. The Chadhuri Declaration has been fully considered but is unpersuasive.
With respect to the above anticipatory rejection of claims 22, 23 and 25 under 35 USC 102(a)(1), the Chadhuri Declaration is unpersuasive because, as noted in MPEP 2131.04, “[e]vidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973).”
With respect to the above rejections under 35 USC 103, according to the Chadhuri Declaration, “a study was undertaken to assess the tackifier/tackiness properties of isosorbide di-(methyl-fumarate) (IDMF).” However, it is unclear exactly which isosorbide di-(methyl-fumarate) (IDMF) was tested. In particular, it is unclear whether it is a compound in instant claim 28 having methyl groups at the wedges, or compound (IV) at col. 9, lines 45-54 of the ‘321 patent.
Furthermore, none of the claims rejected over Chen alone, i.e., claims 22, 23 and 25-27, is limited to isosorbide di-(methyl-fumarate) (IDMF). As noted in MPEP 716.02(d), the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.”
Furthermore, the Chadhuri Declaration is unpersuasive for all claims rejected under 35 USC 103, i.e., claims 22, 23 and 25-28, since the Declaration limited the testing of the compound for tackiness to what appears to be room temperature. Such is insufficient since Chen tested for tackiness over the temperature range of -50°C to 80°C (see Table 1 on p. 30).
In fact, the compound tested by Chen in Table 1 that is a di-methyl ester, i.e., compound No. 8 (see ¶ 0133 for structure), exhibited maximum tackiness at -20°C. Similarly, Zenner noted that the methyl esters in compound No. 12, reproduced below, provided for “lowering of the glass-transition temperature and the temperature at which maximum tack is observed by approximately 30°C.” (See p. 450, 1st col.) As seen in Table 1 of Zenner, compound No. 12 has a maximum tack at 0°C, whereas the corresponding diacid, i.e., compound No. 9 (also reproduced below), has a maximum tack at 35°C.
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Thus, the fact that the Chadhuri Declaration found that the isosorbide di-(methyl-fumarate), which is a dimethyl ester compound, was not tacky at room temperature is not unexpected.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceed-ing in which Patent No. 11,542,275 is or was involved. These proceedings would include interferences, reissues, reexaminations, and litigation. Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is mate-rial to patentability of the claims under consideration in this reissue appli-cation. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN D DIAMOND whose telephone number is (571)272-1338. The examiner can normally be reached Monday through Thursday 5:30 am to 3:00 pm, and Fridays from 5:30 am to 9:30 am.
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, Patricia Engle can be reached on 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Signed:
/ALAN D DIAMOND/Patent Reexam Specialist
Central Reexamination Unit 3991
Conferees:
/JOSEPH R KOSACK/Patent Reexam Specialist
Central Reexamination Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
1 The copy of Zenner accompanying the instant Office action is hereinafter referred to below.