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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This office action is a response to applicant’s communication submitted June 26, 2023, wherein claims 1-4 and 6-8 were preliminarily amended, and claims 10-18 were added.
Claims 1-18 are pending in this application.
Priority
This application is the U.S. national phase of International Application No. PCT/FR2021/052408 filed December 20, 2021, which designated the U.S. and claims priority to FR 2014257 filed December 30, 2020. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been received. The Examiner notes that no English translation has been provided.
Information Disclosure Statement
The information disclosure statement filed June 26, 2023 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of a reference listed that is not in the English language (Written Opinion of the ISA for PCT/FR2021/052408 mailed April 19, 2022, 6 pages.). It has been placed in the application file, but the information referred to therein has not been considered.
Drawings
The drawings are objected to because Figure 1 is blurry and uses the word “contrie”. 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, 4-5, 9, 16-18 are objected to because of the following informalities:
In claim 1 the phrase “as active ingredient” should read “as an active ingredient” or similar.
In claims 4 and 16-18 the phrase “as active ingredient” should read “as active ingredients”.
Claims 1, 5, and 9, the structures are blurry and subscripts slightly overlap with other functional groups:
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.
In claim 5, R group definitions should be separated by a semi-colon rather than a comma to avoid confusion. For example “R1 is chosen from H, SO3-, R2 is chosen” should read “R1 is chosen from H, SO3-; R2 is chosen”.
Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities:
On page 4 of the instant specification, R4 is recited as a variable, however there is no such variable in the structure (line 8).
On page 4 of the instant specification In claim 1 the phrase “as active ingredient” should read “as an active ingredient” or similar (line 6).
On page 5 of the instant specification In claim 1 the phrase “as active ingredient” should read “as an active ingredient” or similar (line 24).
On page 6 of the instant specification the phrase “as active ingredient” should read “as active ingredients” (line 5).
Throughout the specification the structures and structure labels are blurry, and there is slight overlap with subscripts and other functional groups (pg. 4, lines 6-7, 20-22, pg. 6, lines 25-26, pg. 7, lines 26-27, pg. 8, lines 21-22, pg. 9, lines 1-2, pg. 12, lines 8-9, 15-16, pg. 13, lines 1-2, 6-7)
On page 23 of the instant specification, Table 1 is listed as “Tables 1”, but is referred to as “Table 1” on line 5. Additionally, the table is blurry and many of the variables are illegible, for example:
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Appropriate correction is required.
The use of the terms Osigraft®, Inductos®, and Infuse® (pg. 2, line 31), which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 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 1-4 and 6-18 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 claims 1-4, and 15-18: Claim 1 does not define R1 and instead defines R4 which is not a variable in the structure. Thus, a person of ordinary skill in the art would be unable to ascertain the metes and bounds of the invention. For examination purposes, as best understood by the instant specification, the claims will be interpreted such that R1=R4. Claims 2-4 and 15-18 which depend from claim 1 are similarly rejected.
Regarding claims 2, 15-16, and 18: Claim 2 depends from claim 1 and recites inter alia, “comprising at least one pharmaceutically acceptable salt”. Claim 1 recites “the pharmaceutically acceptable salts of these compounds”. It is unclear as written whether the claim is further including the addition of a salt, such as NaCl, or is meant to limit the claims to a pharmaceutically acceptable salt of the compounds. Additionally, the claim further recites “wherein said salt(s) are chosen independently of each other from the sodium salts, the potassium salts, and the lithium salts”. It is similarly unclear whether the claims are reciting the addition of a salt (NaCl) or limiting to a specific type of salt of a compound (i.e. the sodium salt). In the latter case, use of the plural language (i.e. “sodium salts”) renders the claim indefinite because it is unclear whether the claim is meant to specify sodium salts in general, or wherein there are multiple possible sodium salts to be used. Claims 15-16 and 18 which depend from claim 2 are similarly rejected.
Regarding claims 3, 15, and 17-18: Claims 3 and 15 recite the phrase “wherein said excipient is chosen from the injectable solutions of sodium chloride”. There is a lack of antecedent basis for the phrase “the injectable solutions” in the claim. Additionally, it is unclear whether the phrase “injectable solutions” is specifying a specific form of the overall composition (i.e. an injectable solution), merely describing a property/intended use of the sodium chloride excipient, or reciting a structural limitation of the sodium chloride excipient, i.e. a specific form thereof. Claims 17 and 18 which depend from claims 3 and 15 respectively are similarly rejected.
Regarding claims 6 and 10-11: Claim 6 recites both transitional phrases: “comprising”, which is inclusive/open-ended and does not exclude additional, unrecited elements, and “consisting of”, which is closed and excludes additional, unrecited elements (See MPEP 2111.03). Additionally claim 6 starts with, “wherein said biocompatible support is chosen from…”, which implies closed. Usage of these terms render the claims indefinite because it is unclear whether the supports are meant to be open ended or not. Thus, it is unclear what, if anything, is meant to be excluded by use of the terms. Claims 10-11, which depend from claim 6 are similarly rejected.
Regarding claims 6 and 10-11: Claim 6 recites inter alia, “wherein said biocompatible support is chosen from porous biocompatible supports, supports comprising or consisting of ceramic(s), supports comprising or consisting of calcium phosphate, supports including or consisting of the mineral portion of a bone.”. It is unclear whether the phrase “porous biocompatible supports” is meant to be a genus, followed by specific species to be selected from said genus (i.e. the species of calcium phosphate), or is an alternative in the start of a list (porous biocompatible supports or supports comprising or consisting of calcium phosphate). Thus, the claim is rendered indefinite. Additionally, in the latter case wherein it is an alternative, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation porous biocompatible supports or ceramics, and the claim also recites calcium phosphate which is the narrower statement of the range/limitation. According to Vezenkova (Bioactive Materials, 2022, cited on PTO-892), calcium phosphate cements are known bone substitutes (i.e. support), that are both porous and biocompatible (abstract, pg. 110, col. 1, para. 2, pg. 113, col. 1, second to last para.). Vezenkova also discloses that calcium phosphate can be considered a ceramic (pg. 117, col. 1, para. 2). According to the specification, the supports listed are examples of porous biocompatible supports (pg. 7, lines 8-18). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claims 10-11, which depend from claim 6 are similarly rejected.
Regarding claims 7-8 and 12-14: Claim 7 recites inter alia, “A method either for treatment of a pathology generating, as a symptom, at least locally a decrease in bone density, or in a surgical procedure for treating bone defects, or for treating bone fractures….”. The phrase renders the claim indefinite because the scope of the conditions to be treated is unclear. The claim can be interpreted as a method for the treatment of three separate conditions (i.e. a pathology, bone defects, or bone fractures), or two separate conditions whereby one is limited to a surgical procedure (a pathology, or in a surgical procedure for either treating bone defects or fractures). According to the instant specification, the surgical method relates to methods of treating bone defects or bone fractures, separate from the pathology treatment (i.e. the latter interpretation, pg. 8, lines 5-19). However, claim 14, which depends from claim 7, recites inter alia, “wherein the method is performed for treating a pathological bone fracture”. Would this be limiting the pathology or surgical method? Claim 13, which depends from claim 7, recites inter alia, “wherein the method is performed as part of a surgical procedure for treating bone defects, wherein the bone defect is an area of a bone which has a deficiency in bone material.” Could this also be a pathology to be treated? According to the instant specification, a pathological fracture is caused by an decrease in bone density and a bone defect includes an area in the bone material that is less dense (pg. 9, lines 10-15). The broadest reasonable interpretation of “a decrease in bone density” includes a deficiency in bone material as well as bone material that is less dense. The lack of clarity and overlapping scope of claim 7 renders the claim indefinite. Claims 8 and 12-14 which depend from claim 7 are similarly rejected.
Regarding claims 10-11: Claim 10, which depends from claim 6, recites “wherein the support is a biocompatible support comprising biodegradable polymer(s).” Claim 11, which depends from claim 10 and ultimately depends from claim 6, recites “wherein the support is selected from the group consisting of: PLA, polyglycolic acid, poly(lactic-co-glycolic acid), collagen, polyglycolide, chitosan, and polycaprolactone”. In both claims, it is unclear whether the claims attempting to limit the porous biocompatible support of claim 6 to comprise the claimed biodegradeable polymers, or is stating that the support is solely these materials, separate from the porous biocompatible support of claim 6. The lack of clarity renders claims 10-11 indefinite.
Regarding claim 12: Claim 12 recites inter alia, “….for treatment of a pathology selected from the group consisting of:….bone tumors, and cancerous bone tumors.”. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites the broad recitation bone tumors, and the claim also recites cancerous bone tumors which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 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 10-12 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 claims 10-11: Claim 10, which depends from claim 6, recites “wherein the support is a biocompatible support comprising biodegradable polymer(s).” Claim 11, which depends from claim 10 and ultimately depends from claim 6, recites “wherein the support is selected from the group consisting of: PLA, polyglycolic acid, poly(lactic-co-glycolic acid), collagen, polyglycolide, chitosan, and polycaprolactone”. However, claim 6 already limited the support to “porous biocompatible supports”, given that both claims 10 and 11, as written, are aimed at limiting the support, both claims expand, rather than limit instant claim 6.
Regarding claim 12: Claim 12, which depends from claim 7 recites inter alia, “performed for treatment of a pathology selected from…osteopetrosis…”. However, claim 7 recites, “for treatment of a pathology, generating, as a symptom, at least locally a decrease in bone density.”. According to Tong (National Organization for Rare Diseases, 2025, cited on PTO-892) osteopetrosis is a disorder characterized by a general increase in bone density (pg. 2, para. 1). Thus, claim 12 expands, rather than limits, instant claim 7.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dussouy (Chem. Eur. J., 2012, IDS filed June 26, 2023).
Regarding claims 1-2: Dussouy teaches the following target disaccharides:
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and evaluation of the physiological effects of these disaccharides on M. persicae aphids fed on artificial media containing different concentrations of these disaccharides (pg. 10022, col. 1, scheme 1, para. 1). Compounds 1, 3, and 4 meet the limitations of compounds of formula (I) and are not excepted via proviso. Compound 4 is a sodium salt. Dussouy teaches assays to determine activity of the compounds were conducted in 50 mM citrate phosphate buffer (in water), an excipient (pg. 10028, col. 1, para. 3).
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Bultel (WO 2009/098400, IDS filed June 26, 2023). The English translation relied upon has been provided by the Examiner.
Regarding claim 1: Bultel teaches a composition comprising at least one compound of the invention (i.e. includes mixtures of compounds) which are mixed with an excipient to facilitate its use as an antifungal or antibacterial agent (English translation, pg. 8, last para.). The composition of at least one compound of the invention can be used as a chitinase inhibitor, which gives it the property as an insecticide (English translation, pg. 9, paras. 1-2). Bultel teaches the following specific compounds as active compounds of the invention
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and
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(English translation, pg. 11, bottom of scheme).
Bultel does not explicitly teach a composition comprising the compound encompassed by the structural formula of claim 1.
However, Bultel teaches the compounds are of the following formula (A)
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(English translation, pg. 9, paras. 3-4) wherein Y3 can alternatively be a benzyl group, an H atom, or sulphonate radical (English translation, pg. 9, para. 11). Bultel teaches specific compounds wherein Y3 is a benzyl radical (English translation, pg. 7, middle of page). Additionally, Bultel suggests that substitution of sulphonate at any of the X2 or X3 or X4 or Y3 or Y5 positions allows the compound to effectively inhibit the effect of chitinases (English translation, pg. 7, para. 4).
Taken together, given the explicit disclosure that Y3 can alternatively be sulphonate or benzyl among only three possible options, via modification of the explicitly described active compounds, the following compounds are encompassed by the teachings of Bultel: Compounds of claim 1 wherein R1 is H or SO3-, R2 is Ac (COCH3), and R3 is SO3- or benzyl (utilizing formula as recited by instant claim 1).
Claims 3 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Dussouy (Chem. Eur. J., 2012, IDS filed June 26, 2023) as applied to claims 1-2 above in view of Baker (New York State IPM Program, 2018).
Regarding claims 3 and 15: As discussed above, Dussouy teaches the compositions of claims 1-2 comprising the claimed compound and an excipient. Dussouy teaches the compounds are promising candidates for insect-chitinase inhibition (pg. 10021, col. 2, para. 3).
Dussouy does not teach wherein the excipient is an injectable solution of sodium chloride.
However, Baker teaches sodium chloride is a common inert ingredient in many insecticide formulations, where it shows synergistic effects, increases buffering and solubility, and acts as a diluent (pg. 8, insecticidal activity, middle of page).
Taken together, it would have been prima facie obvious to a person of ordinary skill in the art to modify the composition of Dussouy, such that the composition includes sodium chloride as taught by Baker. A person of ordinary skill would have the motivation to do so with a reasonable expectation of success as sodium chloride is a commonly used inert ingredient in insecticidal formulations to increase buffering and solubility. Wherein the compound would be dissolved in a solution, by its nature, would be an injectable solution.
Conclusion
No claims are allowed in this action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ferrer (US 8,394,781, cited on PTO-892) teaches disaccharides, including chondroitin sulphate, for the treatment of bones (abstract).
Couto (FEBS Journal, 2012, cited on PTO-892) teaches synthetic anionic sugar conjugates containing N-acetyl D-glucosamine-6-sulfate sodium salt competitively inhibits the binding of affinity purified rabbit anti-C-T IgG to the C-T extension of cruzipain, a major cysteine proteinase of trypanosoma cruzi (abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL L GALSTER whose telephone number is (571)270-0933. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Y Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.L.G./Examiner, Art Unit 1693
/ERIC OLSON/Primary Examiner, Art Unit 1693