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 August 16, 2023, is a reissue continuation of Serial No. 17/475,109, filed September 14, 2021, now abandoned, which is a reissue of U.S. Patent 10,980,890 (hereafter the '890 patent), which issued from U.S. application Serial No. 16/545,869 (the ‘869 application) with claims 1-22 on April 20, 2021.
The ‘869 application is a continuation of U.S. application Ser. No. 16/005,245, filed Jun. 11, 2018, now U.S. Patent 10,383,949, which is a continuation of U.S. application Ser. No. 14/898,932, filed Dec. 16, 2015, now U.S. Pat. No. 9,993,568, which is a 371(c) National Stage Filing of PCT/KR15/005,299 (hereafter the ‘299 PCT application), filed May 27, 2015, which claims the benefit of priority to Korean Republic Application No. 10-2015-0073161 filed May 26, 2015 and Korean Republic Application No. 10-2014-0064360 filed May 28, 2014.
Application Data Sheet (ADS)
The domestic benefit information in the ADS filed on 06/11/2024 correctly identifies the present application as a continuation of U.S. application Serial No. 17/475,109. However, the ADS is objected to because the domestic benefit information does not also identify the present application as a reissue application of Serial No. 16/545,869, which issued as the ‘890 patent. See the Reissue Application Filing Guide at http://www.uspto.gov/sites/default/files/forms/uspto_reissue_ads_guide_Sept2014.pdf for more information and in particular see the screen shot on page 10 given the sample facts presented on page 9. A corrected ADS is required.
The corrected ADS should comply with 37 CFR 1.76(c)(2), which requires that any changes to an ADS be identified with markings (underline for addition, strike through for deletion). Applicant can also use the Corrected Web-based ADS. See the Quick Start Guide for Corrected Web-based ADS at https://www.uspto.gov/sites/default/fiies/documents/Corrected-WebADS-QSG.pdf.
Sequence Listing
The present reissue application has a sequence listing. During the prosecution of the application that became the ‘890 patent, Applicant filed the requirements for a patent application containing peptide sequence disclosure. However, the required sequence information is not present in the instant reissue application pursuant to 37 CFR 1.804 and 1.821-1.825. As such, Applicant must resubmit all required documents and statements directed to the sequence as well as the CRF in this reissue application to have a compliant sequence that can be processed by SCORE and STIC at the USPTO.
Non-Compliant Amendment
The amendment to the specification filed 08/16/2023 and the amendment to the claims filed 08/15/2025 are improper. The amendments do not comply with 37 CFR 1.173 which sets forth the manner of making amendments in reissue applications. While the improper amendments have been entered and considered, a supplemental paper correctly amending the reissue application is required with Applicant’s next response. An amendment filed after final rejection that fails to comply with 37 CFR 1.173 will not be entered.
All amendment changes must be made relative to the patent to be reissued, not relative to a previous submitted amendment. Pursuant to 37 CFR 1.173(d), any such changes which are made to the specification, including the claims, must be shown by employing the following markings:
(1) The matter to be omitted by reissue must be enclosed in brackets, i.e., single brackets; and (2) The matter to be added by reissue must be underlined.
The non-compliance issues are as follows:
Claims 23-33 are newly added claims relative to the ‘890 patent and thus, must be underlined in their entirety. Also, their status identifier should be “New”, not “Previously Presented”.
The amendment to the specification has changed the two occurrences of “application Ser. No.” to “Application No.” without appropriate markings.
Similarly, the amendment to the specification has changed “application Ser. Nos.” to “Application Nos.” without appropriate markings.
The amendment to the specification has changed “Jun.” and “Dec.” to “June” and “December” without appropriate markings.
The amendment to the specification has changed “U.S. Patent” to “U.S. patent” without appropriate markings.
The seventh line of the amendment to the specification has changed “005,299” to “005299” without appropriate markings. See col. 1, line 11 of the ‘890 patent.
Specification
The disclosure is objected to because of the following informalities: The amendment to the specification adds, via underlining, the bolded heading “Cross-Reference to Related Applications”. This heading is unnecessary and duplicative since col. 1, lines 4-5 of the ‘890 patent specification already provides the heading “CROSS-REFERENCE TO RELATED APPLICATIONS”. The bolded, underlined heading should be left out of the amended paragraph.
Appropriate correction is required.
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 new claims 23-55 directed to a cleavable group, a compound, and method of treating a disease. Claim 23 (with underlining) and claim 34 are representative and reproduced below.
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Defective Reissue Declaration
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 recited in the reissue declaration is as follows:
U.S. Patent No. 10,980,890 is partially inoperative by reason of the Pantentee claiming less than the Patentee had the right to claim in the patent. Pantentee seeks to broaden the claims by adding a new claim. Patentee is entitled to protect the cleavage groups described in the specification.
The error statement is defective because it does not identify an issued claim, e.g., claim 1, to be broadened, and does not identify a single word, phrase, or expression in the claim and how it renders the original patent wholly or partly inoperative or invalid. The corresponding corrective action which has been taken to correct the original patent need not be identified in the oath/declaration. See MPEP 1414.II(B).
A new reissue declaration with a proper error statement is required. An example of a proper error statement is as follows:
This is a broadening reissue. Claim 1 is to be broadened. Claim 1 is unduly narrow in its requirement that W is -C(O)NR’-.
Claims 23-55 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 Rejection - 35 USC § 251, Recapture
Claims 23-33 are rejected under 35 U.S.C. 251 as being an impermissible recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based. In re McDonald, 43 F.4th 1340, 1345, 2022 USPQ2d 745 (Fed. Cir. 2022); Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Youman, 679 F.3d 1335, 102 USPQ2d 1862 (Fed. Cir. 2012); In re Shahram Mostafazadeh and Joseph O. Smith, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984). The reissue application contains claim(s) that are broader than the issued patent claims. The record of the application for the patent family shows that the broadening aspect (in the reissue) relates to claimed subject matter that applicant previously surrendered during the prosecution of the application. Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
As noted in MPEP 1412.02.II, there is a three-step test for recapture: First, we determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims. Second, we determine whether the broader aspects of the reissue claims relate to subject matter surrendered in the original prosecution. Third, we determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule.
As to the first step of the recapture test, reissue claims 23-33 are broader than the issued claims since reissue claims 23-33 do not specify what is attached to W and the carbonyl group C(O) in formula (II) as noted by the two annotation arrows below:
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Issued claim 1 requires that W is attached to -L-A, and that C(O) is attached to -B:
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wherein A is an antibody, B is an active agent, and L comprises an alkylene chain having 1 to 50 carbon atoms and a binding unit represented by Chemical Formula B, C, D, or E:
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With respect to the second step of the recapture test, the broader aspects of reissue claims 23-33 relate to subject matter surrendered in the original application. As noted in MPEP 1412.02.I, the “original application” includes the patent family’s entire prosecution history. U.S. Application Ser. No. 14/865,778 (hereafter the ‘778 application), which issued as U.S. Patent 9,919,057, is a member of the patent family since the ‘778 application is a continuation of the ‘299 PCT application.
During prosecution of the ‘778 application, Applicant presented the following claim 1 in a preliminary amendment filed 09/25/2015:
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In an Office action mailed 09/30/2016, claim 1 and its dependent claims 2-27 were rejected under 35 USC 112(a) for failing to comply with the written description requirement due to the fact the full genus of compounds was not adequately described. The rejection noted that limitations lacking adequate written description include “any C1-20/C1-100hydrocarbyl” for A and B, “any biomaterial or modified biomaterial” for A, and “any linker of an unknown portion of formula I referred to as the self immolative group” for L. (See pp. 7-11 of OA 09/30/2016).
In a response filed 12/28/2016, Applicant amended claim 1 so that A is an antibody and B is an active agent:
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In the accompany Remarks filed 12/18/2016, in response to the 112(a) written description rejection, Applicant argued that the amended claim 1 “is directed to an antibody-drug conjugate and that “it has long been known in the art how to generally prepare antibody-drug agent conjugate”, allowing one of skill in the art to conjugate any antibody to any active agent as defined in the instant claims, thus putting the inventors in possession of the claimed invention.” (See pp. 13-14, emphasis added). Applicant further argued that “[b]ased on the description in the specification of various active agents, one of ordinary skill in the art at the time the application was filed would have understood that the inventors were in possession of the now-claimed compounds of chemical formula I, wherein B is an active agent.” (See p. 15, emphasis added).
In a final rejection mailed 04/25/2020, a 112(a) lack of written description rejection was made due to L being any linker with covalent bonds. The rejection again noted that the full genus of compounds is not adequately described.
In after-final responses filed 07/25/2017 and 10/18/2017, Applicant amended claim 1 to define L and obviate the 112(a) rejection. In particular, with respect to L, claim 1 was further amended to state:
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In the accompanying Remarks filed 07/25/2017 (p. 12) and 10/18/2018 (p. 13), with respect to the 112(a) written description rejection over L, Applicant argued that the amendment overcomes the rejection (emphasis added):
Without conceding the correctness of the rejection, and as discussed above, Applicant has amended claim 1 to recite, in the alternative, the values for L recited in dependent claims 5 and 6, which were not rejected on this basis. Claims 2-3, 12-22, and 24-26 all depend from claim 1. Applicant submits the presently amended claims overcome this rejection, and requests its withdrawal.
Thus, the requirements that A is an antibody, B is an active agent, and L is as defined in said amendments filed 07/25/2017 and 10/18/2017 are surrender generating limitations. Accordingly, the broadening aspects in reissue claims 23-33 relate to subject matter surrendered in the original application.
With respect to the third step of the recapture test, reissue claims 23-33 have entirely eliminated the A, B and L surrender generating limitations. While reissue claims 23-33 are narrower with respect to, for example, the definitions of G and W in claim 1 filed 09/25/2015 in the ‘778 application, and G in reissue claims 23-33 is narrower than G in issued claim 1 of the ‘890 patent, G and W are unrelated to A, B and L. Thus, there is impermissible recapture. See MPEP 1412.02.III.B.1.
Claim Rejection - 35 USC § 251, Original Patent
Claims 23-33 are rejected as not complying with the original patent requirement under 35 U.S.C 251.
As stated in Forum US, Inc. v Flow Valve, LLC, 926 F.3d 1346, 2019 USPQ2d 221227 (Fed. Cir. 2019), for broadening reissue claims, the specification of the original patent must do more than merely suggest or indicate the invention recited in reissue claims; “[i]t must appear from the face of the instrument that what is covered by the reissue was intended to have been covered and secured by the original.” Indus. Chems., 315 U.S. at 676. Stated differently, the original patent “must clearly and unequivocally disclose the newly claimed invention as a separate invention.” Antares, 771 F.3d at 1362. As further noted in MPEP 1412.01, “’The ‘original patent’ standard and the written description requirement are not the same. Where the written description requirement is based on what the skilled artisan would have understood was within the possession of the inventor, recent Federal Circuit case law indicates that the original patent requirement under § 251 requires something more.’ See Ex parte Sandwick, Appeal No. 2018-008369, op. at 22 (PTAB July 23, 2019)”.
Claims 23-33 are directed to “A cleavable group”, i.e., the claims set forth an incomplete compound, i.e., structural formula II. In particular, claims 23-33 do not set forth what is attached to W and what is attached to the carbonyl group in formula II, as noted below by the annotation arrows:
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The ‘890 patent discloses and claims a compound, i.e., a complete compound, comprising a self-immolative group. For example, the ‘890 abstract states:
Provided herein are compounds comprising a self-immolative group, and the compounds comprising a self-immolative group according to the present invention may include a protein (for example, an oligopeptide, a polypeptide, an antibody, or the like) having substrate-specificity for a target and an active agent (for example, a drug, a toxin, a ligand, a detection probe, or the like) having a specific function or activity.
Throughout the ‘890 patent specification, the only compounds disclosed are of chemical formula I,
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which is a complete compound having A-L- attached to W, and -B attached to the carbonyl group, wherein A, L and B are defined (see col. 3, line 10 through col. 4, line 67; col. 13, line 1 through col. 14, line 20; col. 26, line 16 through col. 29, line 42; and claim 1). Nowhere does the specification disclose, in an explicit and unequivocal manner, formula II without A-L- attached to W, and -B attached to the carbonyl group.
Since the ‘890 patent does not clearly and unequivocally disclose the claimed compound portion of formula II as an invention, claims 23-33 are not to the same invention as that disclosed in the original patent and thus, do not comply with the original patent requirement of 35 USC 251(a).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 23-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 23-33 set forth a portion of a compound, not a complete compound. In particular, claims 23-33 do not set forth what is attached to W and what is attached to the carbonyl group in formula II.
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In fact, nowhere is there a “formula II” disclose in the ‘890 patent specification. Rather, the ‘890 patent specification discloses compounds having chemical formula I,
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which has A-L- attached to W and -B attached to the carbonyl group, wherein A, L and B are defined as, for example, in issued claim 1 (see col. 3, line 10 through col. 4, line 67; col. 13, line 1 through col. 14, line 20; col. 26, line 16 through col. 29, line 42; and claim 1).
Applicant’s Remarks filed 08/16/2023 state that “[s]upport for new claims 23-33 can be found throughout the specification and claims, for example at columns 32-61 of U.S. Patent No. 10,980,890.” However, the ‘890 patent specification provides no such support. Instant formula II encompasses a practically limitless number of compounds due to the fact that the instant claims do not define what is attached to W or the carbonyl. Column 32-61 of the ‘890 patent disclose the preparation and testing of a limited number of complete compounds within the scope of chemical formula I, with specific groups attached to W and the carbonyl group. For example, Example 1 starting at col. 32 prepares complete compound 1k:
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.
Furthermore, there is a lack of predictability in the art. The compounds of the ‘890 patent are intended to be used as antibody-drug conjugates (ADCs) (see col. 1, lines 40-67; Experimental Example 5 at cols. 61-62; and col. 65, lines 8-18). However, according to Marei et al, “Potential of antibody-drug conjugates (ADCs) for cancer therapy,” Cancer Cell International (2022), 22:255, pp. 1-12, (hereinafter Marei), “[d]espite promising ADC-induced therapeutic activity against resistant and recurrent cancers, several barriers remain to their widespread use, including unidentified drug resistance mechanisms, toxicity, the lack of predictive prognostic biomarkers, and their clinical advantages over standard therapies.” (See p. 2, 1st col.). Marei concludes by teaching that “ADCs are unique, potent, and unpredictable, and clinical and translational researchers are only beginning to grasp them.” (See p. 9, 1st col., emphasis added).
Similar lack of predictability is taught by Jin et al, “New Technologies Bloom Together for Bettering Cancer Drug Conjugates,” Pharmacological Reviews, 74:680-713, July 2022 (hereinafter “Jin”). Jin teaches that “[a]lthough the development of drug conjugates is flourishing, the development of drug conjugates is arduous.” (See p. 682). Jin teaches that, “a big problem exists in predicting the safety and efficacy of drug conjugates. Correlating the in vivo efficacy and safety of preclinical studies to the clinical trials has proven to be difficult.” (See p. 707). Jin further teaches that “[a] survey of discontinued ADC trials shows two main reasons for the failure of ADCs to move to advanced clinical stages: (1) lack of efficacy and (2) unexpected toxicity.” (See p. 707).
Accordingly, in view of the above, the ‘890 patent specification does not convey to one skilled in the relevant art that the at the time the application was filed, had possession of the claimed invention of formula II, i.e., an incompletely defined compound.
Claims 23-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for complete compounds containing a cleavable group, such as the complete compound represented by Chemical Formula I in issued claim 1, does not reasonably provide enablement for a cleavable group represented by formula II in claim 23 having undefined attachments. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with claims 23-33.
In particular, claims 23-33 do not set forth what is attached to W and what is attached to the carbonyl group in formula II.
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In contrast, the compounds disclosed in the ‘890 patent specification have chemical formula I,
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which has A-L- attached to W and -B attached to the carbonyl group, wherein A, L and B are defined as in, for example, claim 1 of the ‘890 patent (see col. 3, line 10 through col. 4, line 67; col. 13, line 1 through col. 14, line 20; col. 26, line 16 through col. 29, line 42; and claim 1).
In view of the fact that claims 23-33 do not teach what is attached to W and the carbonyl group, claims 23-33 encompass a practically infinite number of compounds. In other words, the breadth of the claims is limitless. However, only a limited number of exemplary compounds are shown at cols. 32-61 of the ‘890 patent specification. All of those compounds are complete compound have a particular A-L- and -B. For example, Example 1 starting at col. 32 prepares the following complete compound 1k:
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, wherein A-L- is
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, and -B is the -MMAF.
Furthermore, there is unpredictability in the art. The claimed compounds are intended to be used as antibody-drug conjugates (ADCs) (see col. 1, lines 40-67; Experimental Example 5 at cols. 61-62; and col. 65, lines 8-18). However, according to Marei, “[d]espite promising ADC-induced therapeutic activity against resistant and recurrent cancers, several barriers remain to their widespread use, including unidentified drug resistance mechanisms, toxicity, the lack of predictive prognostic biomarkers, and their clinical advantages over standard therapies.” (See p. 2, 1st col.). Marei concludes by teaching that “ADCs are unique, potent, and unpredictable, and clinical and translational researchers are only beginning to grasp them.” (See p. 9, 1st col., emphasis added).
Similar lack of predictability is taught by Jin. Jin teaches that “[a]lthough the development of drug conjugates is flourishing, the development of drug conjugates is arduous.” (See p. 682). Jin teaches that, “a big problem exists in predicting the safety and efficacy of drug conjugates. Correlating the in vivo efficacy and safety of preclinical studies to the clinical trials has proven to be difficult.” (See p. 707). Jin further teaches that “[a] survey of discontinued ADC trials shows two main reasons for the failure of ADCs to move to advanced clinical stages: (1) lack of efficacy and (2) unexpected toxicity.” (See p. 707).
In view of the practically limitless scope of claims 23-33 due to not defining what is attached to W and the carbonyl group, the limited number of exemplified compounds in the ‘890 patent specification, and the unpredictability in the art as shown by Marei and Jin, undue experimentation would be required by one of ordinary skill in the art to practice the full scope of claims 23-33. Accordingly, the ‘890 patent specification does not enable the full scope of claims 23-33.
Claims 23-33 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.
Formula II in claim 23 and its dependent claims 24-33 is indefinite because the claims fail to define what is attached to W and what is attached to the carbonyl group as noted below by the annotation arrows. In other words, a complete compound structure is not provided.
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Thus, the metes and bounds for the claim cannot be determined.
In claim 23, the phrase “in each case where the C(O), S or P is directly bound to the phenyl ring, and R’ and R’’ are each …” is confusing because it is unclear whether the C(O), S or P are required to be directly bound to the phenyl ring or if the phrase sets forth a proviso. It is suggested that “where” be removed from the phrase. The same applies to dependent claims 24-33.
Claim 26 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The definition of G set forth in claim 26 is the same as set forth in parent claim 23. Accordingly, claim 26 does not further limit claim 23.
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 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.
Claims 23-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jeffrey et al, “Development and Properties of β-Glucuronide Linkers for Monoclonal Antibody-Drug Conjugates,” Bioconjugate Chem., 2006, 17, pp. 831-840 (hereinafter “Jeffrey”1).
Jeffrey teaches the following three compounds (pp. 835 and 836):
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,
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and
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which read on the claimed compound wherein W is -C(O)NH-, n = 3, each Z is hydrogen, and R1 to R4 are each hydrogen. Accordingly, Jeffrey anticipates claims 23-33.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 23-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,383,949 (hereinafter the ‘949 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With respect to claims 23-28, 31 and 32, claims 9 and 21 of the ‘949 patent are pertinent and reproduced below.
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The compounds in claims 9 and 21 of the ‘949 patent read on instant formula II wherein R1, R2, R3 and R4 are each hydrogen and W is -C(O)NH-. Accordingly, claims 23-28, 31 and 32 are anticipated by claims 9 and 21 of the ‘949 patent.
With respect to instant claim 29, which requires that n is 3, claims 9 and 21 of the ‘949 patent set forth that n is an integer of 1 to 3. The selection of n = 3 from n being an integer of 1 to 3 is at once envisaged, and thus, instant claim 29 is anticipated by claim 9 of the ‘949 patent. See MPEP 2131.02.II.
Instant claims 30 and 33 not only require that n = 3, but also require that each Z is hydrogen. As noted above, claims 9 and 21 of the ‘949 patent further set forth that Z is hydrogen, (C1-C8)alkyl, halogen, cyano or nitro. The ‘949 patent specification at col. 39 discloses the following compounds within the scope of claim 21 having the instant n = 3 and each Z is hydrogen:
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, where MMAF (cols. 33-34) is
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It would have been obvious to one of ordinary skill in the art to have selected compounds within the scope of the ‘949 patent’s claims 9 and 21 where n = 3 and each Z is hydrogen in view of the limited selections of an integer of 1 to 3 for n, and hydrogen, (C1-C8)alkyl, halogen, cyano or nitro for Z in claims 9 and 21, and in view of the compounds disclosed in the ‘949 patent specification within the scope of claim 21 having n = 3 and each Z is hydrogen. 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 ‘949 patent. Accordingly, claims 30 and 33 are rendered obvious by the claims of the ‘949 patent.
Claim 23-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,413,353 (hereinafter the ‘353 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because, for example, claim 17 of the ‘353 patent sets forth the following compound which anticipates the formula in instant claims 23-33:
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wherein the instant W is -C(O)NH-, n = 3, each Z is hydrogen, and each of R1, R2, R3, and R4 is hydrogen.
Claims 23-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,173,214 (hereinafter the ‘214 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because, for example, claim 18 of the ‘214 patent sets forth the following compound which anticipates the formula in instant claims 23-33:
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wherein the instant W is -C(O)NH-, n = 3, each Z is hydrogen, and each of R1, R2, R3, and R4 is hydrogen.
Claims 23-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,167,040 (hereinafter the ‘040 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because, for example, claim 21 of the ‘040 patent sets forth the following compound which anticipates the formula in instant claims 23-33:
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wherein the instant W is -C(O)NH-, n = 3, each Z is hydrogen, and each of R1, R2, R3, and R4 is hydrogen.
Claims 23-49 and 51-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of U.S. Patent 11,827,703 (the ‘703 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘703 patent disclose several compounds, such as the compound set forth below from claim 25 of the ‘703 patent, which anticipate instant claims 23-33:
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wherein the instant W is -C(O)NH-, n = 3, each Z is hydrogen, and each of R1, R2, R3, and R4 is hydrogen.
With respect to claims 34-38, 48, 49, and 53, the above compound from claim 25 of the ‘703 patent anticipates these claims since “B” in the above compound is an active agent, and “Ab” is the antibody material set forth in claim 1 of the ‘703 patent, from which claim 25 is dependent.
With respect to claims 39-47, in support of the antibody present in the above compound in claim 25 of the ‘703 patent, the ‘703 patent specification teaches that the antibody may comprise an amino acid motif, preferably at a C-terminus of Ab, that is recognized by an isoprenoid transferase (see col. 11, lines 36-42). For example, the amino acid motif may be CYYX (see col. 11, lines 36-42). The isoprenoid transferase is farnesyl protein transferase or geranylgeranyl transferase (see col. 17, lines 24-26). The person of ordinary skill in the art would be motivated to choose an amino acid motif as here claimed to fully practice the scope of the ‘703 patent claims as the ‘703 patent specifies such a motif as suitably present with the antibody. Therefore, claims 39-47 are rendered obvious.
With respect to claims 51 and 52, in support of the term “active agent”, the ‘703 patent specification teaches that suitable active agents include an immunomodulatory compound, an anticancer agent, an antiviral agent, an antibacterial agent, an antifungal agent, an antiparasitic agent, or a combination thereof (see col. 20, lines 30-36). The person of ordinary skill in the art would be motivated to choose an immunomodulatory compound, an anticancer agent, an antiviral agent, an antibacterial agent, an antifungal agent, an antiparasitic agent, or a combination thereof to fully practice the scope of the ‘703 patent claims as the ‘703 patent specifies such materials as suitable active agents. Therefore, claims 51 and 52 are rendered obvious.
With respect to claims 54 and 55, the claims of the ‘703 patent do not teach a method of treating a disease such as cancer with the compound in claim 25 of the ‘703 patent.
However, the ‘703 patent specification teaches that a contemplated utility for the compound is treating cancer (see col. 53, lines 53-63).
It would have been obvious to one of ordinary skill in the art to have used the compound in claim 25 of the ‘703 patent for treatment of cancer because such is a contemplated utility of the compound, as taught by the ‘703 patent specification. See MPEP 804.II.B.1.
Claims 23-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent 11,654,197 (the ‘197 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘197 patent disclose several compound species, including the compound species set forth below from claim 14, which anticipate the formula in instant claims 23-33:
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wherein the instant W is -C(O)NH-, n = 3, each Z is hydrogen, and each of R1, R2, R3, and R4 is hydrogen.
Claims 23-49 and 51-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent 11,707,533 (the ‘533 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘533 patent disclose several compounds, such as the compound set forth below from claim 25 of the ‘533 patent, which anticipate the formula in instant claims 23-33:
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wherein the instant W is -C(O)NH-, n = 3, each Z is hydrogen, and each of R1, R2, R3, and R4 is hydrogen.
With respect to claims 34-38, 48, 49, and 53, the above compound in claim 25 of the ‘533 patent anticipates these claims since “B” in the above compound is an active agent, and “Ab” is the antibody material set forth in claim 1 of the ‘533 patent, from which claim 25 is dependent.
With respect to claims 39-47, in support of the antibody present in the above compound in claim 25, the ‘533 patent specification teaches that the antibody may comprise an amino acid motif, e.g. at a C-terminus of Ab, that is recognized by an isoprenoid transferase (see col. 22, lines 3-25; and col. 10, lines 42-44). For example, the amino acid motif may be CYYX (see col. 22, line 22). The isoprenoid transferase is farnesyl protein transferase or geranylgeranyl transferase (see col. 13, lines 17-19). The person of ordinary skill in the art would be motivated to choose an amino acid motif as here claimed to fully practice the scope of the ‘533 patent claims as the ‘533 patent specifies such a motif as suitably present with the antibody. Therefore, claims 39-47 are rendered obvious.
With respect to claims 51 and 52, in support of the term “active agent”, the ‘533 patent specification teaches that suitable active agents include an immunoregulatory compound, anti-cancer agent, antiviral, antibacterial, antifungal, antiparasitic or a combination of these (see col. 26, lines 33-35). The person of ordinary skill in the art would be motivated to choose an immunoregulatory compound, anti-cancer agent, antiviral, antibacterial, antifungal, antiparasitic or a combination of these to fully practice the scope of the ‘533 patent claims as the ‘533 patent specifies such materials as suitable active agents. Therefore, claims 51 and 52 are rendered obvious.
With respect to claims 54 and 55, the claims of the ‘533 patent do not teach a method of treating a disease such as cancer with the compound in claim 25 of the ‘533 patent.
However, the ‘533 patent specification teaches that a contemplated utility for the compound is for treating cancer (see Abstract).
It would have been obvious to one of ordinary skill in the art to have used the compound in claim 25 of the ‘533 patent for treatment of cancer because such is a contemplated utility of the compound, as taught by the ‘533 patent specification. See MPEP 804.II.B.1.
Claims 23-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent 12,398,124 (the ‘124 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘124 patent disclose several compound species, such as the compound species set forth below from claim 27, which anticipate the formula in claims 23-33:
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wherein the instant W is -C(O)NH-, n = 3, each Z is hydrogen, and each of R1, R2, R3, and R4 is hydrogen.
Claims 23-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 10, 11, 13, 15, 16, 19, 23-25, 30, 32, 33, 45-48, 51-53, 57, 61 and 63 of copending Application No. 16/964,965 (the ‘965 application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘965 application disclose several compounds, such as the compound set forth below from claim 33 of the ‘965 application, which anticipate the formula in instant claims 23-33:
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wherein the instant W is -C(O)NH-, n = 3, each Z is hydrogen, and each of R1, R2, R3, and R4 is hydrogen.
With respect to claims 34-38, 48, 49, and 53, the above compound from claim 33 of the ‘965 application anticipates these claims since “B” in the above compound is an active agent, and the bond overlaid with a wavy line is attached to an antibody.
With respect to claims 39-47, in support of the antibody present in the above compound in claim 33, the ‘965 application specification teaches that the antibody may comprise an amino acid motif such as CYYX (see p. 26). The farnesyl protein transferase and geranylgeranyl transferase of instant claim 47 are known isoprenoid transferases. The person of ordinary skill in the art would be motivated to choose an amino acid motif as here claimed to fully practice the scope of the ‘965 application claims as the ‘965 application specifies such a motif as suitably present with the antibody. Therefore, claims 39-47 are rendered obvious.
With respect to claims 51 and 52, in support of the term “active agent”, the ‘965 application specification teaches that suitable active agents include an immunoregulatory compound, anti-cancer agent, antiviral agent, antibacterial agent, antifungal agent or antiparasitic agent (see p. 33). The person of ordinary skill in the art would be motivated to choose an immunoregulatory compound, anti-cancer agent, antiviral, antibacterial, antifungal agent or antiparasitic agent to fully practice the scope of the ‘965 application claims as the ‘965 application specifies such materials as suitable active agents. Therefore, claims 51 and 52 are rendered obvious.
With respect to claims 54 and 55, the claims of the ‘965 application do not teach a method of treating a disease such as cancer with the compound in claim 33 of the ‘965 application.
However, the ‘965 application specification teaches that a contemplated utility for the compound is for treating cancer (see Abstract).
It would have been obvious to one of ordinary skill in the art to have used the above compound in claim 33 of the ‘965 application for treatment of cancer because such is a contemplated utility of the compound, as taught by the ‘965 application specification. See MPEP 804.II.B.1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 23-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 140-155 of copending Application No. 18/209,299 (the ‘299 application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘299 application disclose the following compound species, reproduced below from claim 140, which anticipates the formula in instant claims 23-33:
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wherein the instant W is -C(O)NH-, n = 3, each Z is hydrogen, and each of R1, R2, R3, and R4 is hydrogen.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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. 10,980,890 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 obl