DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I (i.e., claims 1-9, drawn to a modified lysine of formula (I)) in the reply filed on 10/14/2025 is acknowledged.
Priority
The present application claims status as a 371 (National Stage) of PCT/US2021/029528 filed April 28th 2021, and claims the benefit under 35 U.S.C 119 (e) to U.S. Provisional Application No. 63/017,281 filed April 28th 2020.
Information Disclosure Statement
The IDS filed on 04/21/2023 has been considered by the Examiner.
Specification
The disclosure is objected to because of the following informalities: Incorrect Figure Description. It is noted that page 26, lines 15 and 17-18 describes Fig. 1B and refers to the green signal (neutral pH) and red signal (acidic pH). However, the patent or application file does not contain any figure/drawing executed in color. Appropriate correction is required.
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.
1. Claims 1 and 4-9 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. Claim 1 is drawn to a modified lysine of formula (I), wherein “… A is a bond; and Q is a bond…” Since the instant specification does not define the term “bond”, pursuant to MPEP 2111.01, under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the time of the invention. HyperPhysics teaches that a net attractive force between atoms forms a chemical bond and that there are two extreme cases of chemical bonds: covalent bond (i.e., bond in which one or more pairs of electrons are shared by two atoms) and ionic bond (i.e., bond in which one or more electrons from one atom are removed and attached to another atom, resulting in positive and negative ions which attract each other) (see HyperPhysics, “Chemical Bonds” available online on 8/23/1999, retrieved from https://hyperphysics.phy-astr.gsu.edu/hbase/Chemical/bond.html on 12/17/2025). HyperPhysics also teaches that other types of bonds include metallic bonds and hydrogen bonding (see HyperPhysics, pg. 1). Additionally, Ball teaches that one of the key ambiguities in chemical bonding lies with the relationship between the strength and length of a bond (see Ball, P., “What is a Bond?” first available online on 01/29/2014 at https://www.chemistryworld.com/features/what-is-a-bond/6983.article at pg. accessed on 12/17/2025 at pg. 6, paragraph 2). Chemists are accustomed to the idea that strong bonds tend to be short, and weak ones long; but this doesn’t always seem to mean that atoms that are close enough together to be bonded necessarily are (see Ball, pg. 6, paragraph 2). By the same token, some bonds can seemingly be stretched beyond their normal breaking point without ‘snapping’ (see Ball, pg. 6, paragraph 2).
Therefore, an ordinary skilled artisan would not be able to ascertain the metes and bounds of the modified lysine with respect to wherein A is a bond; and B is a bond, because it has not been clearly defined whether A and B form one single bond, a double bond, a triple bond, a covalent bond, an ionic bond, a metallic bond, a hydrogen bond, a short bond or a bond stretched beyond its normal breaking point without snapping (i.e., a long bond). It has also not been clearly defined whether there is a molecule or atom between bond A and bond B; other than one or more pairs of electrons shared by two atoms (i.e., as in a covalent bond); or other than positive and negative ions which attract each other (i.e., as in anionic bond). As such, the claim recitation wherein A is a bond; and Q is a bond is ambiguous and/or unclear. For examination purposes and to advance prosecution, the Examiner is interpreting the recitation wherein “A is a bond; and Q is a bond” as a single bond in the lysine structure. As such, claim 1 and dependent claims 4-9 are indefinite.
2. Claims 1 and 4-9 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. In the instant case, independent claim 1 recites a modified lysine of formula (I) wherein A, Q, B and (R1)n are variables. However, it is noted that the epsilon nitrogen in the lysine structure forms an amide bond with A (i.e.,
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). Therefore the carbonyl group between the ε-nitrogen in the lysine sidechain and variable A is always present (i.e., see dotted-line square). Thus when A is a heterocyclyl optionally substituted on carbon by one or more R2; and if R2 includes a carbonyl group as in carboxy, carbamoyl, acetyl, acetoxy, acetylamino, N-methylcarbamoyl, N-ethylcarbamoyl, N,N-dimethylcarbamoyl, N,N-diethylcarbamoyl, N-methyl-N-ethylcarbamoyl, Methoxycarbonyl, and Ethoxycarbonyl then an ordinary skill artisan would be unable to determine whether formula (I) comprises two carbonyl groups adjacent to each other or whether the carbonyl group present in R2 is eliminated. Therefore claim 1 and dependent claims 4-9 are indefinite.
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.
3. Claims 1, 4-5 and 7-8 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 claims contain 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.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus.
Independent claim 1 recites a modified lysine of formula (I)
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wherein:
A is C1-6 alkylene, or heterocyclyl; wherein said heterocyclyl is optionally substituted on carbon by one or more R2; and wherein if said heterocyclyl contains an -NH- moiety that nitrogen may be optionally substituted by a group selected from RA; and Q is a bond;
or alternatively, A is a bond; and Q is a bond;
Ring B is morpholinyl or thiomorpholinyl; wherein if said morpholinyl or thiomorpholinyl contains an -NH- moiety that nitrogen may be optionally substituted by a group selected from RC;
R1 and R2 are each independently selected from halo, nitro, cyano, hydroxy, trifluoromethoxy, trifluoromethyl, amino, carboxy, carbamoyl, mercapto, sulphamoyl, methyl, ethyl, methoxy, ethoxy, acetyl, acetoxy, methylamino, ethylamino, dimethylamino, diethylamino, N-methyl-N-ethylamino, acetylamino, N-methylcarbamoyl, N-ethylcarbamoyl, N,N-dimethylcarbamoyl, N,N-diethylcarbamoyl, N-methyl-N-ethylcarbamoyl, methylthio, ethylthio, methylsulphinyl, ethylsulphinyl, mesyl, ethylsulphonyl, methoxycarbonyl, ethoxycarbonyl, N-methylsulphamoyl, N-ethylsulphamoyl, N,N-dimethylsulphamoyl, N,N- diethylsulphamoyl and N-methyl-N-ethylsulphamoyl;
n is 0-4;
RA and RC are independently selected from methyl, ethyl, propyl, isopropyl, acetyl, mesyl, ethylsulphonyl, methoxycarbonyl, ethoxycarbonyl, propoxycarbonyl, butoxycarbonyl, carbamoyl, N-methylcarbamoyl, N-ethylcarbamoyl, N,N-dimethylcarbamoyl, N,N-diethylcarbamoyl and N-methyl-N-ethylcarbamoyl.
Therefore the scope of claim 1 and dependent claims 4-9 encompass a lysine backbone (i.e.,
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) modified at the epsilon nitrogen, where the modification encompasses the variables A, Q, B and R1 (i.e.,
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); where A is C1-6 alkylene, or heterocyclyl with optional substitutions and variations (i.e., see R2 and RA group descriptions above), or a bond; Q is a bond; Ring B is morpholinyl or thiomorpholinyl; R1 is independently selected from a group of 41 chemical functional groups/substituents (see list above) and n is 0 or 1 or 2 or 3 or 4. As such the scope of the claimed formula encompasses a vast array of possible combinations that would conform to the instantly claimed formula (I).
Applicants reduced to practice four examples that describe the synthesis of (2S)-2-amino-6-{[6-(morpholin-4-yl)pyridine-3-carbonyl]amino}hexanoic acid (N6-(6-morpholinonicotinoyl)-l-lysine) (see instant specification, pg. 30, Example 1); (2S)-2-amino-6-[(thiomorpholine-3-carbonyllamino]hexanoic acid (N6-(thiomorpholine-3-carbonyl)-L-lysine), (see instant specification, pg. 31, Example 2); (2S)-2-amino-6-[2-(morpholin-4-yl)acetamido]hexanoic acid (N6-(2-morpholinoacetyl)-L-lysine) (see instant specification, pg. 33, Example 3); and Poly(L-lysine) and PEG-Poly(L-lysine) polypeptides (see instant specification, pg. 34, Example 4).
In Example 1, the specification teaches the implementation of method 1 and method 2 which depict the removal of the Fmoc protecting group from the modified lysine (see instant specification, pg. 30). The final product obtained after deprotection is a lysine modified at the epsilon nitrogen where A is heterocyclyl, Q is a bond, Ring B is morpholinyl and n is 0 in (R1)n (see instant specification, pg. 30). Likewise, method 5 is also taught as part of Example 1, for the synthesis of N2-(((9H-fluoren-9-yl)methoxyl)-N6-(4-(tert-butoxycarbonyl)thiomorpholine-3-carbonyl)-L-lysine (see instant specification, pg. 30 and pg. 31). The end product of synthesis method 5 yields a lysine modified at the epsilon nitrogen where A is a bond, Q is a bond, Ring B is thiomorpholine and n is 0 in (R1)n. Additionally a Boc protecting group is attached to the N in the thiomorpholine and a Fmoc protecting group is attached to the α-amino group (see instant specification, pg. 31)
In Example 2, methods 1 and 2 are applied to remove the Fmoc and Boc protecting groups from a modified lysine bearing the groups at the α-amino group (i.e., Fmoc) and at the thiomorpholinyl (i.e., Boc). Thereby resulting in a modified lysine wherein A is a bond, Q is a bond, Ring B is thiomorpholynyl and n is 0 in (R1)n (see instant specification, pg. 32). Method 6, is also part of Example 2 and it depicts the synthesis of N2(1-{[(morpholin-4-yl)acetyl]oxy}pyrrolidine-2,5-dione)-L-lysine where the end product is a modified lysine with a Fmoc protecting group at the α-amino group wherein A is C1-6 alkylene, Q is a bond, Ring B is morpholinyl and n is 0 in (R1)n.
In Example 3, methods 1 and 2 were used in the synthesis of (2S)-2-amino-6-[2-(morpholin-4-yl)acetamido]hexanoic acid (N6-(2-morpholinoacetyl)-L-lysine) where the Fmoc protecting group is removed from the α-amino group, thereby resulting in a modified lysine wherein A is C1-6 alkylene, Q is a bond, Ring B is morpholinyl, and n is 0 in (R1)n.(see instant specification, bottom of pg. 33).
Example 4 of the instant specification illustrates the intermediate and final polymer products obtained when Poly(L-Lysine) and PEG-Poly(L-Lysine) polypeptides are modified with morpholinyl or thiomorpholinyl. Thereby resulting in a polymer product PLL(M) or PEG-PLL (M) wherein A is C1-6 alkylene or heterocyclyl or a bond, Q is a bond, Ring B is morpholinyl or thiomorpholinyl and n is 0 in (R1)n (see instant specification, pg. 34, box). From the teaching of the specification, it is understood that the examples reduced to practice only show an already modified lysine wherein the Fmoc protecting groups are either attached or removed and Poly(L-Lysine) and PEG-Poly(L-lysine) polypeptides wherein A, Q and Ring B are present and but not representative of the genus instantly claimed genus.
The written description requirement may be met by providing a representative number of species of the genus. In the instant case, the specification teaches four examples where different synthesis methods are employed to add or remove a Fmoc or Boc protecting group to a modified lysine of formula (I) wherein A is C1-6 alkylene or heterocyclyl or a bond, Q is a bond, Ring B is morpholinyl or thiomorpholinyl and n is 0 for (R1)n. The specification is silent about a modified lysine of formula (I) where the variables A, Q, ring B and (R1)n are other than the options previously mentioned. Thus, evidence of four positive integrant and replicative experiments wherein the variables of formula (I) are limited to wherein A is C1-6 alkylene or heterocyclyl or a bond, Q is a bond, Ring B is morpholinyl or thiomorpholinyl and n is 0 for (R1)n is not sufficient for the skilled artisan to envisage what constitutes a necessary core structure of formula (I). Therefore, claims 1 and 4-8 do not meet the written description requirement.
Claim Rejections - 35 USC § 102
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.
3. Claims 1, 4-5 and 7are rejected under 35 U.S.C. 102(a)(1) as being anticipated by National Center for Biotechnology Information (2025). PubChem Compound Summary for CID 67831919, (2S)-2-amino-6-(morpholine-4-carbonylamino)hexanoic acid. Created on 11/30/2012. Retrieved December 19, 2025 from https://pubchem.ncbi.nlm.nih.gov/compound/67831919, (herein after “PubChem”) (cited in the IDS filed on 04/21/2023).
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For claims 1, 4-5, and 7; PubChem discloses the chemical structure depiction for (2S)-2-amino-6-(morpholine-4-carbonylamino)hexanoic acid with molecular formula C11H21N3O4 (see pg. PubChem, pg. 1). Represented by the structure depicted in the image below. As it can be appreciated from the chemical structure depicts an L-lysine derivative, which consists of a hexanoic acid backbone (i.e., a central six carbon amino acid chain) with an L-amino group at the C2 position and a modified amino group at the C6 position (see structure above, taken from PubChem). The structure also incorporates a morpholine ring attached via a carbonyl group at the epsilon amino group of the hexanoic lysine backbone (see structure above) Thereby PubChem’s disclosure of CID 67831919 corresponds to the instantly claimed modified lysine of formula (I) wherein A is a bond, Q is a bond, ring B is morpholinyl, and n=0 for (R1)n, as recited in instant claim 1. As discussed in the 35 U.S.C. 112(b) rejection above, the Examiner is interpreting the recitation wherein “A is a bond, and Q is a bond” as a single bond in the lysine structure.
Additionally, with respect to the optional language included in the claims (e.g., wherein the heterocyclyl is optionally substituted, or wherein nitrogen may be optionally substituted by a group selected from RC). Pursuant to MPEP 2111.04, claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. Therefore, the claim limitations followed by the optional language do not limit the claims to a particular structure.
As such, PubChem’s compound summary for CID 67831919 anticipates claims 1, 4-5 and 7.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
103 - KSR Examples of 'Rationales' Supporting a Conclusion of Obviousness
(Consistent with the "Functional Approach" of Graham)
Further regarding 35 USC 103(a) rejections, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) (KSR) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Also, a reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976).
4. Claims 1, 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over National Center for Biotechnology Information (2025). PubChem Compound Summary for CID 67831919, (2S)-2-amino-6-(morpholine-4-carbonylamino)hexanoic acid. Created on 11/30/2012. Retrieved December 19, 2025 from https://pubchem.ncbi.nlm.nih.gov/compound/67831919, (herein after “PubChem”) (cited in the IDS filed on 04/21/2023), in view of Kacan et al., Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, vol 118, 2014,pp. 572-577 (herein after “Kacan”).
Regarding claim 1, see discussion of PubChem above.
Regarding claims 6 and 8, PubChem teaches the chemical structure depiction for (2S)-2-amino-6-(morpholine-4-carbonylamino)hexanoic acid with molecular formula C11H21N3O4 (see pg. PubChem, pg. 1). However, PubChem does not teach wherein Ring B is thiomorpholinyl as recited in instant claim 6.
Kacan teaches that morpholine, thiomorpholine and piperazine with an acetamide pendant group are known to be as tridentate chelates (see pg. 572, introduction). Nitrogen, oxygen and sulfur-containing heterocyclic frameworks are prevalent subunits in biologically active molecules nitrogen, oxygen and sulfur-containing heterocyclic frameworks are prevalent subunits in biologically active molecules such as antidepressants and antifungal compounds (see pg. 572, introduction). Kacan also teaches that thiomorpholine analogs are associated with a variety of pharmacological activities including anti mycobacterial, antibacterial, analgesic and anti-inflammatory (see pg. 572, introduction). Kacan also teaches that complexes of N-substituted morpholine, thiomorpholine and piperazine are of particular interest not only for their ability to form complexes but also high thermodynamic stability and kinetic inertness (see pg. 572, introduction). The thermal behavior of the complexes with acetamide pendant derivatives of piperazine, morpholine and thiomorpholine have attracted attention, the attention being focused on the species that could have some practical applications (see pg. 572, introduction).
From the teachings of the references, the Examiner recognizes that it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention modified PubChem CID 67831919 by substituting the morpholine ring attached via a carbonyl group at the epsilon amino group of the hexanoic lysine backbone with a thiomorpholine with an acetamide pendant in order to arrive at the modified lysine of claim 1, wherein A is a bond, Q is a bond and Ring B is thiomorpholinyl. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so because thiomorpholine with an acetamide pendant is known as a tridentate chelate as taught by Kacan. One of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success given that morpholine with an acetamide pendant is also known as a tridentate chelate; given that nitrogen, oxygen and sulfur-containing heterocyclic frameworks are prevalent subunits in biologically active molecules; and given that complexes of N-substituted thiomorpholine are of particular inertness for their ability to form complexes and also for their high thermodynamic stability and kinetic inertness as taught by Kacan. Therefore, substituting the morpholine ring attached via a carbonyl group at the epsilon amino group of the hexanoic lysine backbone of CID 67831919 with thiomorpholine with an acetamide pendant would support the instantly claimed modified lysine wherein ring B is thiomorpholinyl by constituting a simple substitution of one known element for another to obtain predictable results and/or some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention pursuant to KSR.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references discussed above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
5. Claims 1 and 4-9 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/698,811 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because, the instantly claimed modified lysine of formula (I) is a species of a peptide dendron claimed in copending Application No. 18/698,811.
Regarding instant claim 1, copending Application No. 18/698,811 claims:
A peptide dendron comprising one or more residues derived from a modified lysine of formula (I)
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, wherein: A is a bond, C1-6alkylene, carbocyclyl or heterocyclyl; wherein said carbocyclyl or heterocyclyl may be optionally substituted on carbon by one or more R2; and wherein if said heterocyclyl contains an -NH- moiety that nitrogen may be optionally substituted by a group selected from RA; Q is a bond, carbocyclyl or heterocyclyl; wherein said carbocyclyl or heterocyclyl may be optionally substituted on carbon by one or more R3; and wherein if said heterocyclyl contains an -NH- moiety that nitrogen may be optionally substituted by a group selected from RB; Ring B is morpholinyl or thiomorpholinyl; wherein if said morpholinyl or thiomorpholinyl contains an -NH- moiety that nitrogen may be optionally substituted by a group selected from RC; R1, R2 and R3 are each independently selected from halo, nitro, cyano, hydroxy, trifluoromethoxy, trifluoromethyl, amino, carboxy, carbamoyl, mercapto, sulphamoyl, methyl, ethyl, methoxy, ethoxy, acetyl, acetoxy, methylamino, ethylamino, dimethylamino, diethylamino, N-methyl-N-ethylamino, acetylamino, N-methylcarbamoyl, N-ethylcarbamoyl, N,N-dimethylcarbamoyl, N,N-diethylcarbamoyl, N-methyl-N-ethylcarbamoyl, methylthio, ethylthio, methylsulphinyl, ethylsulphinyl, mesyl, ethylsulphonyl, methoxycarbonyl, ethoxycarbonyl, N-methylsulphamoyl, N-ethylsulphamoyl, N,N-dimethylsulphamoyl, N,N-diethylsulphamoyl and N-methyl-N-ethylsulphamoyl; n is 0, 1, 2, 3, or 4; RA, RB are RC are independently selected from methyl, ethyl, propyl, isopropyl, acetyl, mesyl, ethylsulphonyl, methoxycarbonyl, ethoxycarbonyl, propoxycarbonyl, butoxycarbonyl, carbamoyl, N-methylcarbamoyl, N-ethylcarbamoyl, N,N-dimethylcarbamoyl, N,N-diethylcarbamoyl and N-methyl-N-ethylcarbamoyl (see ‘811, claim 1).
Regarding instant claim 4, copending Application No. 18/698,811 claims: wherein n is 0 (see ‘811, claim 4).
Regarding instant claims 5-8, copending Application No. 18/698,811 claims: wherein A is a bond, C1-6alkylene or heterocycly (see ‘811, claim 2); wherein Q is a bond (see ‘811, claim 3); wherein Ring B is morpholinyl (see ‘811, claim 5); wherein Ring B is thiomorpholinyl (see ‘811, claim 6); wherein: A is a bond, methylene or pyridyl; Q is a bond; Ring B is morpholinyl or thiomorpholinyl; and n is 0 (see ‘811, claim 7); the peptide dendron of claim 1, wherein the residue derived from a modified lysine is of formula (IB)
PNG
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157
418
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Greyscale
, (see ‘811, claim 8).
Regarding instant claim 9, copending Application No. 18/698,811 claims: the peptide dendrone of claim 1, wherein the residue derived from a modified lysine is selected from: (S)-2-amino-6-{[6-(morpholin-4-yl)pyridine-3-carbonyl]amino}hexanoic acid; (S)-2-amino-6-[(thiomorpholine-3-carbonyl)amino]hexanoic acid; and (S)-2-amino-6-[2-(morpholin-4-yl)acetamido]hexanoic acid (see ‘811, claim 9).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/CLAUDIA ESPINOSA/Patent Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654