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 December 20, 2023, wherein claims 1-83 were canceled and claims 84-101 were added. This application is a 371 of PCT/US21/61675 filed December 2, 2021 and claims the benefit of US provisional application 63/121,037 filed December 3, 2020.
Claims 84-101 are pending in this application.
Drawings
The drawings are objected to because figures 2-3 have blurry R subscripts that are illegible. Additionally some the bond lines do not clearly show connectivity:
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(figure 2, letter B). 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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. In the instant case, the phrase “Disclosed herein” is utilized.
The disclosure is objected to because of the following informalities:
On page 55, the phrase “B12.alpha..” should be corrected to B12 alpha if that is what is meant (bottom of page 55).
On page 95 there is a double period, “ethanol..” (para. 00306).
Appropriate correction is required.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (pgs. 17-18, paras. 0063-0064). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 90 and 96 are objected to because of the following informalities:
Claim 90 recites the phrase “Ci- C20” which should read “C1-C20”.
Claim 90 recites “n > land” which should read “n > 1 and”.
Claim 96 ends in a double period, one period should be deleted.
Appropriate correction is required.
Claim Interpretation
Regarding claims 84, 90, and 96 which are directed towards a derivative of hyaluronic acid (a compound) and recites inter alia ”….wherein the in-vitro hyaluronidase degradation rate is slower than unmodified hyaluronic acid.”. Wherein the prior art teaches the derivative as claimed thereby anticipating the claim, this description is an inherent property of the compound. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer (See MPEP 2112 (I)).
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 84-101 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 claims 86-88, 91-94, and 98-100: Claims 86-88, 91-94, and 98-100 each recite limitations to the R1 group recited by independent claims 84, 90, and 96. For example, claim 84 recites inter alia “….wherein R1 is a substituted or unsubstituted aromatic moiety….”. Claim 86 which directly depends from claim 84 and recites, “wherein R1 comprises a carboxylic acid group, or a salt, or ester thereof.”. In each case, it is unclear whether the claims are attempting to limit R1 to the recited group specifically (i.e. R1=COOH), or to a substituted aromatic moiety wherein the dependent claim recites the substitution (i.e. benzoic acid). Claims 88, 94, and 100 recite “….wherein R1 comprises a benzene ring.”. Similarly, it is unclear whether this benzene ring is to be encompassed by the phrases “substituted or unsubstituted aromatic moiety”, is a benzene ring separate from the recited aromatic moieties, or is a substitution on said substituted aromatic moiety. This lack in clarity of the scope of the claims, renders them indefinite. The Examiner suggests amending the claims such that they read, “wherein R1 is a substituted aromatic moiety, wherein the substituted aromatic moiety comprises a carboxylic acid group….” or wherein the “substituted or unsubstituted aromatic moiety is benzene” or similar in order to clarify the scope.
Regarding claims 84-101: Claims 89, 95, and 101 each recite limitations to the hyaluronic acid derivatives recited by independent claims 84, 90, and 96, by reciting “….wherein the derivative of hyaluronic acid is reacted with a cross-linking agent to form a crosslinked polymer comprising a reaction product of the derivative of hyaluronic acid and the crosslinking agent.”. However, this product by process limitation leads to a different hyaluronic derivative that a person of ordinary skill in the art would not consider to be encompassed by independent claims 84, 90, and 96. The claim is attempting to limit a claim drawn to a compound by reacting that compound to form a new compound not encompassed by the original scope as understood by a person of ordinary skill in the art. The instant specification separates hyaluronic acid derivatives and crosslinked forms of hyaluronic acid derivatives (pg. 2, para. 0007), thereby acknowledging them as separate classes of compounds. Thus it is unclear what the full scope of the phrase “a derivative of hyaluronic acid” recited by the claims encompass. Thus, claims 84-101 are rendered indefinite.
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 86-87, 89, 91-93, 95, 98-99, and 101 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 86-87, 91-92, and 98-99: Claims 86-87, 91-93, and 98-99 each recite limitations to the R1 group recited by independent claims 84, 90, and 96. For example, claims 84, 90, and 96 recites inter alia “….wherein R1 is a substituted or unsubstituted aromatic moiety….”. Claims 86, 91, and 98 which directly depend from claims 84, 90, and 96 respectively and recite, “wherein R1 comprises a carboxylic acid group, or a salt, or ester thereof.” Claims 87, 92, and 99 which directly depend from claims 84, 90, and 96 respectively and recite, “wherein R1 comprises a hydroxyl group.”. However, R1 is limited to aromatic moieties and does not recite carboxylic acids or hydroxy groups as alternatives. Thus, claims 86-87, 91-93, and 98-99 expand rather than limit their independent claims.
Regarding claims 89, 95, and 101: Claims 89, 95, and 101 each recite limitations to the hyaluronic acid derivatives recited by independent claims 84, 90, and 96, by reciting “….wherein the derivative of hyaluronic acid is reacted with a cross-linking agent to form a crosslinked polymer comprising a reaction product of the derivative of hyaluronic acid and the crosslinking agent.”. However, this product by process limitation leads to a different hyaluronic derivative that a person of ordinary skill in the art would not consider to be encompassed by independent claims 84, 90, and 97. The claim is attempting to limit a claim drawn to a compound by reacting that compound to form a new compound not encompassed by the original scope as understood by a person of ordinary skill in the art. Thus, the claims are expanding, rather than limiting the independent claims.
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 84-101 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gravett (WO 2019/046834, international filing date September 1, 2018, IDS filed June 2, 2023).
Regarding claims 84-101: Gravett teaches a composition comprising a derivative of a polymeric polyhydric alcohol, e.g., hyaluronic acid (HA), wherein derivatives of a polymeric polyhydric alcohol may comprise the derivatives as disclosed above for polyhydric polymers (pg. 6, para. 0019). Gravett teaches that the polymers of the disclosure have hyaluronidase degradation rate that is the same as or less than that of hyaluronic acid that is not derivatized (pg. 62, para. 0188). For example, HA-(OCH2CH2SO2CH2CH2-X-R1-Y)n; (Y-R2-X-CH2CH2SO2CH2CH2O)m-HA-(OCH2CH 2S02CH2CH2-X-R1-Y)n; (CH 2=CH-SO2CH2CH2O )m-HA-(OCH2CH 2SO2CH2CH2-X-R1-Y)n; or (CH2=CH-SO2CH2CH2O)m-HA, where HA is hyaluronic acid or other polyhydric polymer, X is S or NH, R1 is a substituted or unsubstituted C1-C20 aliphatic or aromatic moiety, R2 is a substituted or unsubstituted C1-C20 aliphatic or aromatic moiety, and where applicable, wherein R1 and R2 are different from each other, Y is one or more of H, a carboxylic acid group or a salt or ester thereof, a hydroxyl group, a sulfonic acid group or a salt thereof, or an amine group; wherein n and m are each integers, and n ≥ 1 and m ≥ 1 A composition may further comprise an excipient (pgs. 6-7, para. 0019). Gravett teaches the reactions to produce the derivatives can involve different thiol containing compounds (pg. 24, para. 0083). Gravett teaches the preparation of a divinyl sulfone (DVS) modified HA wherein the hydroxyl substitution is about 25 % (pg. 87-88, paras. 0272). Gravett teaches the production of a DVS modified HA with octanethiol, 2-mercaptobenzoic acid, or thiophenol (i.e. R1 is C8 aliphatic, benzene-COOH, benzene-OH, pg. 89, para. 0275, pg. 95, para. 0285, pg. 97, para. 0288). The substitution of the benzoic acid moiety was 10 % (pg. 95, para. 0285). Gravett teaches the HA can modified twice with 33% hydroxy substitution (i.e. R1 and R2 groups, pgs. 103, para. 0297-0298). Gravett teaches crosslinking of the modified HA derivatives (pg. 104, para. 0299, drawings, figure 2). Although Gravett does not explicitly teach an example wherein the R1 and R2 groups are different, wherein Gravett establishes the derivatives can contain the claimed R groups (i.e. aromatic, aliphatic), can be reacted twice, and states that the R1 and R2 are different to each other in other embodiments, a person of ordinary skill in the art can at once envisage the claimed arrangement based on the disclosure of Gravett (See MPEP 2131.02 (III)).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 84-101 rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. US 11,440,976 (cited on PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 84-101: Patented claim 1 teaches the following derivatives:
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. Patent claims 6-8 teach wherein in the process of preparing the polymers, 0.25-50% of the hydroxyl groups are modified. Thus, the claimed derivatives necessarily possess this feature. Patented claim 12 teaches wherein the polymer is crosslinked. Thus, the hyaluronic derivatives instantly claimed are anticipated by the patent. Although the patented claims do not teach wherein the in-vitro hyaluronidase degradation rate is slower than unmodified hyaluronic acid, wherein the prior art teaches the derivative as claimed thereby anticipating the claim, this description is an inherent property of the derivative, absent evidence to the contrary. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer (See MPEP 2112 (I)).
Claims 84, 86-90, 92-96, 98-101 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. US 12,351,656 (cited on PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 84, 86-90, 92-96, 98-101: Patented claim 1 teaches a coating for a medical device comprising the instantly claimed hyaluronic acid derivatives:
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The disclosed derivatives anticipate the claims. Patented claim 2 teaches the coating is crosslinked. Although the patented claims do not teach wherein the in-vitro hyaluronidase degradation rate is slower than unmodified hyaluronic acid, wherein the prior art teaches the derivative as claimed thereby anticipating the claim, this description is an inherent property of the derivative, absent evidence to the contrary. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer (See MPEP 2112 (I)).
Claims 85, 91, and 97 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. US 12,351,656 (cited on PTO-892) as applied to claims 84, 86-90, 92-96, 98-101 above in view of Gravett (WO 2019/046834, IDS filed June 2, 2023).
Regarding claims 85, 91, and 97: As discussed above Patent ‘656 teaches the derivatives of claims 84, 90, and 96.
The claims do not specify the percentage of modified hydroxyl groups as recited by instant claims 85, 91, and 97.
However, Gravett teaches a composition comprising a derivative of a polymeric polyhydric alcohol, e.g., hyaluronic acid (HA), wherein derivatives of a polymeric polyhydric alcohol may comprise the derivatives as disclosed above for polyhydric polymers (pg. 6, para. 0019). Gravett teaches that the polymers of the disclosure have hyaluronidase degradation rate that is the same as or less than that of hyaluronic acid that is not derivatized (pg. 62, para. 0188). For example, HA-(OCH2CH2SO2CH2CH2-X-R1-Y)n; (Y-R2-X-CH2CH2SO2CH2CH2O)m-HA-(OCH2CH 2S02CH2CH2-X-R1-Y)n; (CH 2=CH-SO2CH2CH2O )m-HA-(OCH2CH 2SO2CH2CH2-X-R1-Y)n; or (CH2=CH-SO2CH2CH2O)m-HA, where HA is hyaluronic acid or other polyhydric polymer, X is S or NH, R1 is a substituted or unsubstituted C1-C20 aliphatic or aromatic moiety, R2 is a substituted or unsubstituted C1-C20 aliphatic or aromatic moiety, and where applicable, wherein R1 and R2 are different from each other, Y is one or more of H, a carboxylic acid group or a salt or ester thereof, a hydroxyl group, a sulfonic acid group or a salt thereof, or an amine group; wherein n and m are each integers, and n ≥ 1 and m ≥ 1 A composition may further comprise an excipient (pgs. 6-7, para. 0019). Gravett teaches the preparation of a divinyl sulfone (DVS) modified HA wherein the hydroxyl substitution is about 25 % (pg. 87-88, paras. 0272). Gravett teaches the production of a DVS modified HA with octanethiol, 2-mercaptobenzoic acid, or thiophenol (i.e. R1 is C8 aliphatic, benzene-COOH, benzene-OH, pg. 89, para. 0275, pg. 95, para. 0285, pg. 97, para. 0288). The substitution of the benzoic acid moiety was 10 % (pg. 95, para. 0285). Gravett teaches the HA can modified twice with 33% hydroxy substitution (i.e. R1 and R2 groups, pgs. 103, para. 0297-0298).
Taken together, it would have been prima facie obvious to a person of ordinary skill in to modify the derivatives of the patented claims and the art arrive at the claimed values as taught by Gravett. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success because values within this range are typically obtained when preparing hyaluronic acid derivatives modified with DVS and aromatic/aliphatic thiols.
Conclusion
No claims are allowed in this action.
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