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 .
Priority
The instant application, filed 11/24/2024, is a 371 filing of PCT/US23/66308, filed 04/27/2023, which claims domestic priority to U.S. provisional application no. 63/363,848, filed 04/29/2022.
Preliminary Amendments and Claim Status
The preliminary amendment filed on 09/15/2026 is acknowledged and entered.
Claims 20-21 are added;
Claims 1-21 are pending and are under prosecution.
Drawings
The drawings filed on 10/24/2024 objected to under 37 CFR § 1.83(a) for the following reasons:
The different data types are indistinguishable in Figure 2A. The figure lacks a figure key to describe the different data types. The figure must be remade with a figure key describing the different types of data represented.
The set of Figures 3A-C are warped, with an aspect ratio that makes the figures difficult to interpret.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR § 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR § 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 4, 12, and 17 are objected to for the following informalities:
The claims contain the following grammatical errors:
Claim 1 recites, “said hydrocarbon group including a methylene group”
Claim 4 recites, “wherein and said compound”
Claim 12 recites, “bonded to a to an oxygen””
Claim 17 recites “ or dispersed said a physiologically tolerable diluent”
The grammatical errors identified above require appropriate correction.
Furthermore, claim 1 uses a combination of parentheses and brackets to designate the type of groups found in R4. The claim recites, “about 2 carbon atoms (an ethylene group), and a length that is less than that of a saturated chain of about 20 carbon atoms [an eicosylene group].” For the purposes of consistency, Applicant should choose either parentheses or brackets consistently throughout the claim.
Further regarding claim 4, the claim recites “wherein the R1-4 moieties are as described above.” However, above claim 4 is claim three, which falls outside of the dependency chain of claim 4. This language is improper, and must be amended.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 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.
Claims 1-19 and 21 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 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 1-19 and 21 of the instant application are drawn to compounds having following substituents:
R1 is trans-2-phenylcyclopropyl or a trans-2-(4-fluorophenyl)cyclopropyl group
R2 is trans-2-phenylcyclopropyl or a trans-2-(4-fluorophenyl)cyclopropyl group
R3 is trans-2-phenylcyclopropyl or a trans-2-(4-fluorophenyl)cyclopropyl group
R4 is a —C(O)NH—CH2— bonded to a hydrocarbyl group of about C2-C20 further bonded to i) a phenyl group that includes a substituent selected from the group consisting of a hydroxyl, amino, carboxy, C1-C6 alkyl carboxylate, sulfo, C1-C6 alkyl sulfonate, fluoro, azido and an ethynyl group, ii) a hydroxyl, a mercaptan, amine, mono- or disubstituted amine, an azido group or iii) to an oxygen, nitrogen or sulfur atom that is part of a substituent group that is selected from the group consisting of an amino acid, ether, ester, carbonate, carbamate, thioether, thioester, thiourea, amido, mono- or disubstituted amide, urea, and a N′-mono or N′,N′-disubstituted urea
35 U.S.C. § 112(a) and the first paragraph of pre-AIA 35 U.S.C. § 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc); Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111,1114 (Fed. Cir. 1991); see also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing the history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a claim’s enablement is not equally conclusive of that claim’s satisfactory written description"). The written description requirement has several policy objectives. "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert, denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaffv. Wells Bees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); EliLilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm.,927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991). An application specification may show actual reduction to practice by describing testing of the claimed invention.
In the present case, the important factors leading to a conclusion of inadequate written description is the lack of a representative number of species that characterizes the entire claimed genus and accounts for variations between species of the genus.
In the instant specification, there is no disclosure of compounds having the following claimed substituents:
R1 as a trans-2-(4-fluorophenyl)cyclopropyl group
R2 as a trans-2-(4-fluorophenyl)cyclopropyl group
R3 as a trans-2-(4-fluorophenyl)cyclopropyl group
R4 as a —C(O)NH—CH2— bonded to a hydrocarbyl group of about C2-C20 further bonded to i) a phenyl group that includes a substituent selected from the group consisting of a carboxy, C1-C6 alkyl carboxylate, sulfo, C1-C6 alkyl sulfonate, fluoro, azido and an ethynyl group, ii) a mono- or disubstituted amine, or iii) to an oxygen, nitrogen or sulfur atom that is part of a substituent group that is selected from the group consisting of an ether, carbonate, thioether, thioester, thiourea, amido, disubstituted amide, urea, and a N′-mono or N′,N′-disubstituted urea
The instant specification (see amendment to the specification filed 09/15/2026) teaches compounds which are characterized as having only the following substituents:
R1 is trans-2-phenylcyclopropyl
R12 is trans-2-phenylcyclopropyl
R3 is trans-2-phenylcyclopropyl
R4 is a —C(O)NH—CH2— bonded to a hydrocarbyl group of about C2-C20 further bonded to i) a phenyl group that includes a substituent selected from the group consisting of a hydroxyl and amino, ii) a hydroxyl, a mercaptan, amine, or an azido group or iii) to an oxygen or nitrogen that is part of a substituent group that is selected from the group consisting of an amino acid, ester, carbamate, or mono-substituted amide
Therefore, the compounds described in the instant specification detail only a limited number of the total substituents claimed (see substituents 1-4, above). All working examples presented in the instant specification are related to the compounds containing a fraction of the total claimed substituents (see substituents 9-12, above).
There are no working examples in the instant specification for the wide range of substituents claimed, but for which evidence of possession has not been provided (see substituents 5-8, above). Thus, the instant specification does not provide any evidence that Applicant was in possession of the claimed invention prior to the effective filing of the instant application.
Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that: ...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966(1997); In re Gosteli, 872 F.2d 1008, 1012,10 USPQ2d 1614, 1618 (Fed Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.") Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. For example, disclosure of only a method of making the invention and the function may not be sufficient to support a product claim other than a product-by-process claim. See, e.g., Fiers v. Revel, 984 F.2d at 1169, 25 USPQ2d at 1605; Amgen, 927 F.2d at 1206, 18 USPQ2d at 1021.
Thus, since Applicant has not described in adequate detail methods to synthesize compounds containing the claimed substituents, or provided evidence that said compounds have been characterized, or that they exist, an ordinary skilled artisan could not completely envisage Applicants’ invention. Moreover, it is clear that the written description requirement has not been met since Applicant has not provided any evidence that Applicant was in possession of the claimed invention prior to the effective filing of the instant application. Thus, claims 1-19 and 21 of the instant application are not supported by the instant specification and thus a rejection under 35 U.S.C. § 112 (a) for failing to comply with the written description requirement is proper.
Claims 17-19 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 enhancing an immunogen-specific IgG response in mammals using a subset of compounds of Formula (I), it does not reasonably provide enablement for the use of any compound of claim 1 to achieve the recited about 2 to about 4 times titer enhancement. The specification does not provide sufficient information to support the instant claims as recited.
The instant specification fails to provide information that would allow the skilled artisan to fully practice the instant invention without undue experimentation. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) the nature of the invention;
(2) the state of the prior art;
(3) the relative skill of those in the art;
(4) the predictability or unpredictability of the art;
(5) the breadth of the claims;
(6) the amount of direction or guidance presented;
(7) the presence or absence of working examples; and
(8) the quantity of experimentation necessary.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention: Claims 17-19 of the instant application are drawn to methods of using the compounds of Formula (I) as vaccine adjuvants to enhance immunogen-specific IgG immune responses. The claims encompass a vast genus of structurally diverse compounds administered with any immunogen to any species to achieve a specified fold titer enhancement.
Breadth of the claims: The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims. The rejected claims are extremely broad. Applicant claims that the claimed compounds can be used to enhance immunogen-specific IgG titers by about 2 to about 4 times when co-administered with an immunogen. Thus, the cited claims are deemed very broad since these claims read on the full genus of Formula (I) which includes widely structurally diverse compounds.
State of the Prior Art: The state of the art according to Yang et al. (J Med Chem, Volume 65, Issue 13, pages 9230–9252, published June 29, 2022), hereinafter Yang, generally recognizes toll-like receptors TLR1/TLR2 agonists as vaccine adjuvants capable of enhancing both innate and adaptive immune responses across species (Abstract). However, the art specifically teaches that adjuvant activity within this class is very sensitive to structural modification (page 9233). The disclosure by Yang systematically demonstrates that incorporation of three ethylene glycol units into the sidechain of Formula (I) reduces potency by >1000 fold (Figure 4). The disclosure further teaches that replacing BocNH-glycine with nearly any other amino acid causes >10-fold potency loss (Figure 7, Compound 57-79). The disclosure further teaches that even conservative changes such as N-methylation of the glycine nitrogen or replacement of an ester oxygen with an amide NH diminished activity (Figure 7, Compounds 70 and 71). Therefore, the prior art teaches that most compounds within the scope of claim 1 would not be expected to function as adjuvants, let alone to produce the specific 2- to 4- fold IgG titer enhancement recited in the claims.
Predictability/Unpredictability in the Art: The pharmaceutical arts, particularly the treatment of cancer, are well-recognized as highly unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. The courts have upheld that in unpredictable arts, a greater degree of specificity is required to satisfy the enablement requirement.
According to the state of the art, the relationship between diprovocim structure and biological activity is inherently unpredictable. Isosteric substitutions that would be expected to behave similarly based on general medicinal chemistry principles produce wildly divergent outcomes, according to the teachings of Yang. These discontinuities cannot be rationalized from known TLR1/TLR2 binding models, because the fourth side chain extends into solvent beyond receptor dimerization interface (see page 9231, Yang), where no structural basis exists for predicting which substituents will or will not enhance activity. The art of TLR agonists design therefore does not permit a skilled artisan to predict whether a given compound within the genus of claim 1 will possess adjuvant activity based on structure alone.
Guidance of the Specification/Working Examples: Applicant has only provided working examples suggesting that a limited number of the compounds of claim 1 may function as TLR1/TRL2 agonists and may serve as vaccine adjuvants in vivo. Furthermore, the specification’s own data contradicts the recited titer range. Figures 9D-F show that OVA alone produces near-baseline observance values, while diprovocim-1 + OVA and diprovocim-X + OVA produce absorbance values approximately 10- to 30-fold higher. At no point does the specification disclose a compound or experimental condition that produces the “about 2 to about 4 times” enhancement recited the instant claims. The claimed range appears to have no basis in the disclosed data. The skilled artisan reviewing the specification would find no guidance on how to practice the method that achieves only 2- to 4 times enhancement, because every working example falls outside of that range. Thus, the specification fails to provide sufficient evidence in support of the method in using the broad genus of compounds to elicit the specific outcome as recited in the instant claims.
The Quantity of Experimentation Required: In order to practice Applicants invention, it would be necessary for one to design and conduct an exhaustive amount of complex experiments to demonstrate that each compound within the genus of claim 1 possesses adjuvant activity sufficient to produce the recited about 2 to about 4 times IgG titer enhancement.
The art establishes that TLR1/TLR2 agonist activity is highly unpredictable based on structural loan. The data demonstrates at structurally minimal changes produce dramatic and unforeseen swings in potency. The demonstrated variability is not akin to a gradual structure activity trend that a skilled artisan could extrapolate from. Therefore, in order to practice the claimed invention, the amount of experimentation required would be considered undue and burdensome. Such experimentation would necessarily include synthesis and full biological characterization of each compound within the genus, in vitro TNF-a dose-response assays, in vivo immunization studies across multiple immunogens and species, as well as the determination of the dose required to achieve the specific 2- to 4-fold IgG titer enhancement as recited. The specification provides in vitro data for two compounds (diprovocim-1 and diprovocim-x) with a single antigen (OVA) in one mouse strain. The data shows enhancement outside of the recited 2- to 4-times range. Accordingly, determining which compounds within the genus possess adjuvant activity, with which immunogens, and under what conditions the recited 2- to 4-times titer enhancement could be achieved would require extensive, individualized experimentation, amounting to undue burden.
In conclusion, Genentech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”. A method of enhancing an immunogen-specific IgG titer by about 2- to 4-times using the full genus of the compounds of Formula (I) with any immunogen in any species is not enabled by the instant specification.
Claim Rejections - 35 U.S.C. § 112 (b)
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 1-21 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.
Regarding claim 1, the claim recites “trans-2-(4-fluorophenyl)cyclopropyl.” This limitation is determined to be indefinite because it is unclear to which carbon atom the stereochemical designation of “trans” should be applied. The naming of the substituent is considered to be ambiguous, and does not comply with IUPAC naming standards. As such, a person of ordinary skill in the art would not be able to ascertain the structure of the substituent encompassed by the name designation. Accordingly, the limitation deems the claim indefinite.
Further regarding claim 1, the claim recites that the methylene group of R4 is either: “i) a phenyl group that includes a substituent selected from the group consisting of a hydroxyl, amino, carboxy, C1-C6 alkyl carboxylate, sulfo, C1-C6 alkyl sulfonate, fluoro, azido and an ethynyl group, ii) a hydroxyl, a mercaptan, amine, mono- or disubstituted amine, an azido group or iii) to an oxygen, nitrogen or sulfur atom that is part of a substituent group that is selected from the group consisting of an amino acid, ether, ester, carbonate, carbamate, thioether, thioester, thiourea, amido, mono- or disubstituted amide, urea, and a N′-mono or N′,N′-disubstituted urea.” The claim further recites wherein said substituent group “contains a chain of atoms that include zero to four oxygens, zero to two sulfur atoms, and zero to four nitrogen atoms, with the proviso that the sum of the sulfur, nitrogen and oxygen atoms in the substituent is at least one, and not greater than eight.” It is unclear whether “said substituent group” and the proviso put forth applies to all three alternatives i), ii), and iii). That is, ambiguity exists as to which “substituent group” is referenced, and where the proviso actually applies. A person of ordinary skill in the art would not be able to determine with reasonable certainty to which of the recited substituent groups the proviso regarding the heteroatom count applies.
Regarding claim 1, the phrase "about 2 carbon atoms (an ethylene group)" and “about 20 carbon atoms [an eicosylene group]”, and [a tetracosylene group] render the claim indefinite because it is unclear whether the limitations in parenthesis and brackets are part of the claimed invention.
Further regarding claim 1, the claim recites “a total length that is about that of a saturated chain of about 2 carbon atoms (an ethylene group), and a length that is less than that of a saturated chain of about 20 carbon atoms [an eicosylene group]” and “a saturated chain of about 24 carbon atoms.” The use of the term “about” to modify both the lower and the upper bounds renders the metes and bounds of the claim indefinite. While the term “about” may be acceptable in certain contexts, is used here to modify chain lengths as short as two carbon atoms, which introduces reasonable uncertainty. A person of ordinary skill in the art would not be able to determine with reasonable certainty whether, for example, a chain length equivalent to one carbon atom falls within or outside the scope of the claim (see MPEP § 2173.05 (b)).
Regarding claim 8, the claim recites “R4 has a saturated chain length of about 6 to about 16 carbon atoms.” For the reasons set forth above, the claim is determined to be indefinite.
Regarding claim 16, the claim recites “R4 has a saturated chain length of about 10 to about 14 carbon atoms.” For the reasons set forth above, the claim is determined to be indefinite.
Regarding claim 17, the claim recites “wherein the enhancement in IgG titer is about 2 to about 4 times the titer observed.” For the reasons set forth above, the claim is determined to be indefinite.
Regarding claims 2-21, the claims depend on a claim rejected as being indefinite (claim 1) and fail to remedy the indefiniteness of the claim on which they depend. Thus, the claims are dually rejected as indefinite.
Claim Rejections - 35 U.S.C. § 112 (d)
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 11, 20, and 21 are 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.
Regarding claim 11, the claim recites “a phenyl group that includes a substituent selected from the group consisting of .. a mercaptan.” This limitation fails to further narrow limitations of claim 8, and claim 1, on which claim 11 depends. A phenyl group substituted with a mercaptan is not encompassed by the limitations of claim 1 or claim 8 (see alternative i). Claim 11 thus recites subject matter that is not a narrowing of the claims on which claim 11 depends. Because claim 11 introduces a substituent not found in the listing of the independent claim, the claim is determined to be of improper dependent form.
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Regarding claims 20 and 21, the claims recite several compounds and substituents wherein the hydrocarbyl group of R4 is bound to a carbonyl carbon—such as in the compound displayed on the right (the second compound of claim 20). This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of R4 in claim 1, on which claims 20 and 21 depend. Specifically, the hydrocarbyl group is defined only as being bound to i) substituted phenyl, ii) hydroxyl, a mercaptan, amine, mono- or disubstituted amine, an azido group or iii) to an oxygen, nitrogen or sulfur atom and is part of a list of functional groups. The hydrocarbyl group is not defined as being bound to a carbonyl carbon. For all the reasons set forth above, a compound wherein the hydrocarbyl group is bound to a carbonyl carbon is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
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Further regarding claims 20 and 21, the claims recite several compounds and substituents wherein the hydrocarbyl group of R4 is bound to an alkyne functional group—such as in the compound displayed on the left (the 18th compound of claim 20). This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of R4 in claim 1, on which claims 20 and 21 depend. Specifically, the hydrocarbyl group is defined only as being bound to i) substituted phenyl, ii) hydroxyl, a mercaptan, amine, mono- or disubstituted amine, an azido group or iii) to an oxygen, nitrogen or sulfur atom and is part of a list of functional groups. The hydrocarbyl group is not defined as being bound to an alkenyl moiety. For all the reasons set forth above, a compound wherein the hydrocarbyl group is bound to an alkenyl moiety is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
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Further regarding claims 20 and 21, the claims recite several compounds and substituents wherein the hydrocarbyl group of R4 is bound to an unsubstituted phenyl group —such as in the compound displayed on the right (the 22nd compound of claim 20). This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of R4 in claim 1, on which claims 20 and 21 depend. Specifically, the hydrocarbyl group is defined only as being bound to i) substituted phenyl, ii) hydroxyl, a mercaptan, amine, mono- or disubstituted amine, an azido group or iii) to an oxygen, nitrogen or sulfur atom and is part of a list of functional groups. The hydrocarbyl group is not defined as being bound to an unsubstituted phenyl. For all the reasons set forth above, a compound wherein the hydrocarbyl group is bound to an unsubstituted phenyl moiety is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
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Further regarding claims 20 and 21, the claims recite several compounds and substituents wherein the hydrocarbyl group of R4 is bound to a halo-substituted phenyl group—such as in the compound displayed on the left (the 25th compound of claim 20). This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of R4 in claim 1, on which claims 20 and 21 depend. Specifically, the hydrocarbyl group is defined only as being bound to i) phenyl substituted by hydroxyl, amino, carboxy, C1-C6 alkyl carboxylate, sulfo, C1-C6 alkyl sulfonate, fluoro, azido and an ethynyl group. The hydrocarbyl group is not defined as being bound to a halo-substituted phenyl. For all the reasons set forth above, a compound wherein the hydrocarbyl group is bound to a halo-substituted phenyl moiety is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
Further regarding claims 20 and 21, the claims recites several compounds in which the hydrocarbyl together with the substituent group of R4 is longer than the length of a tetracosylene group —such as in the compound displayed on the right, below (the 54th compound of claim 20). This limitation
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contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of R4 in claim 1, on which claims 20 and 21 depend. Specifically, the hydrocarbyl group is defined only as being a length less than that of a saturated chain of about 24 carbon atoms [a tetracosylene group]. The hydrocarbyl group together with the substituent bonded to it is not defined as being longer than the length of 24 carbon atoms. For all the reasons set forth above, a compound wherein together with the substituent bonded to is longer than the length of 24 carbon atoms is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
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Further regarding claims 20 and 21, the claims recite several compounds and substituents wherein the sum of the sulfur, nitrogen and oxygen atoms in the substituent is greater than eight in the definition of R4—such as in the compound displayed on the left (the 19th to last compound of claim 20). This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of R4 in claim 1, on which claims 20 and 21 depend. Specifically, the hydrocarbyl group is defined only as containing a chain of atoms that include zero to four oxygens, zero to two sulfur atoms, and zero to four nitrogen atoms, with the proviso that the sum of the sulfur, nitrogen and oxygen atoms in the substituent is at least one, and not greater than eight. The substituent of R4 it is not defined having more than eight sulfur, nitrogen and oxygen atoms. For all the reasons set forth above, a compound wherein R4 has more than eight sulfur, nitrogen and oxygen atoms is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
With respect to the example compounds included within the above rejections based on subject matter that is not within the scope of the claim on which it depends: throughout the claim, numerous compounds which fail to further limit claim 1 with respect to the definition of R4 are recited that have not been included or integrated in this rejection. The exemplary compounds are in no way a complete listing of the compounds and substituents within the claim which fail to further limit claim 1. Over 80 unique compounds have been listed in claim 20. In the interest of brevity, only a few examples of the various substituents which contain subject matter that is not within the scope of claim 1 have been included, so as to guide Applicant in future amendments. To make the record clear, many more compounds listed in claim 20 and substituents listed in claim 21 are identified as including subject matter beyond that which is defined by claim 1. Applicant is expected to properly address every instance in which unsupported subject matter is included in all compounds in any forthcoming amendments to claims 20 and 21, based on the substituents identified herein. Particular attention should be paid to MPEP § 608.04, regarding new matter in any potential forthcoming amendments to the dependent claim, as well as the independent claims.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
Claim Rejections - 35 U.S.C. § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 20 and 21 are rejected under 35 U.S.C. § 102(a)(1) and (a)(2) as being anticipated by Beutler and Boger (US 11,040,959 B2, effectively Jun 29, 2016, for the purposes of 35 U.S.C. § 102(a)(2)).
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Claim 20 and 21 recite compound Registry Number: RN 2170867-70-4. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 2170867-70-4. Entered STN: 24 Jan 2018] (left, the 22nd compound of claim 20).
Beutler and Boger teach all racemates of RN 2170867-70-4 (compound 11, Figure 3), included here for comparison (right). The claimed compound is anticipated by the prior art disclosure. It is of note that this compound is not the only compound anticipated by the patented disclosure. Applicant is asked a thorough in determining which compounds are anticipated by the prior art disclosure.
Correspondence
No claim is allowed.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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