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 .
Applicant’s election of Group I, claims 1-5, 9, 11, 13, 16, 26-27, 29-32 and 34 in the reply filed on 30 March 2026 is acknowledged. Since applicant did not traverse the restriction the election/restriction requirement is deemed proper and is therefore made FINAL. An Action on the merits of claims 1-5, 9, 11, 13, 16, 26-27, 29-32 and 34 is contained herein.
Group II, claims 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Priority
This application is a 371 of PCT/IL22/50391 filed 04/13/2022. PCT/IL22/50391 claims the benefit of 63/184,962 filed 05/06/2021 and the benefit of 63/174,111 filed 04/13/2021.
The parent application 63/174,111 to which priority is claimed is seen to provide adequate support under 35 U.S.C. 112 for claims 1-5, 9, 11, 13, 16, 26-27, 29-32 and 34 of this application.
Drawings
The drawings are objected to because in Figure 1 the label indicating the parameter plotted in the X- and Y- axis, and the legend provided at the top within the boxed part are fuzzy. 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 Rejections - 35 USC § 103
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.
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.
Claim(s) 1-5, 9, 11, 13, 16, 26-27, 29-32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Meunier et al (WO 2020/003298 A1; cited in IDS filed 10/30/2024) in view of Kablik et al (Dermatologic Surgery, 2009, 35, 302-212; cited in IDS filed 10/30/2024).
Meunier et al teaches a composition comprising a polymer which is hyaluronic acid (HA). It comprises a first HA chain and a second HA chain which are crosslinked via one or more linkers comprising an unsaturated moiety bound to a tetrazine moiety. The crosslinking degree is 0.2 to 4% (paras 013, 017, 022, 027 and 047; part of the limitations of claims 1 and 26, part a), (i)-(iii)). Meunier teaches the use of one or more comprising a compound represented by formula (A) and (B) (para 009; limitation of claims 2 and 30). The unsaturated moiety comprises a styrene moiety having formula I A-D (para 010-011; limitation of claim 3). The linkers can also comprise compounds of formula (C) or (D) (para 012; limitation of claims 4 and 30), and one or more linkers which comprise a first compound derived from norbornene moiety selected from compound of formula II A-G, and a second compound derived from tetrazine selected from formula III A-F, wherein the first and second compound are covalently bound via a bond selected from amide, amine (para 013-014, 016; limitation of claim 5, 31-32 and 34).
The crosslinking degree is in the range of 0.2 to 4%. The composition further comprises 0.1 to 30wt% non-crosslinked HA out of the total HA content. This means that 70% of the first and second HA chains are crosslinked. The first and second HA chains have an average molecular weight of 100,000 to 4,000,000 (paras 047, 024 and 017; part of the limitations of claims 9, 13, 26, claim 27 regarding percentage of unmodified chain; limitation of claim 29 regarding molecular weight of first and second HA chain). The polymer has a phase angle of 0.1 to 10o and an elastic modulus of 10 to 1000 Pa (paras 018-019; part of the limitation of claims 13, 16 regarding elastic modulus; limitation of claim 26 regarding phase angle and limitation of claim 27 regarding elastic modulus).
Meunier et al does not teach the weight ratio between water soluble HA and said polymer within said composition is less than 10% as in claim 1, solubility as in claims 9 and 13, concentration and solubility as in claim 11, extrusion force as in claims 16, 27, composition wherein an unmodified chain as in part (b) in claim 26, and concentration as in claim 29.
Kablik et al teaches that the particular use of hyaluronic acid-based dermal fillers is based on several physical parameters including molecular weight, modification and crosslinking, concentration, modulus, swelling, particle size and extrusion force (p.303-307). Chemical modification and crosslinking are necessary to improve the mechanical properties of HA and its residence time at the implant site. HA is commonly modified at the carboxylic acid and/or the hydroxyl group (p.304). Crosslinking improves biomechanical properties while maintaining biocompatibility and biological activity. Increasing cross-link density strengthens the hydrogel network, thereby increasing the hardness or stiffness of the gel (p.304). Cross-linking reagents, conditions, gel concentration and degree of swelling can affect the rate of HA degradation. Total HA concentrations are typically a combination of insoluble HA gel and soluble-free HA gel, wherein free HA is added as a soluble fluid component to the gel to facilitate extrusion of the filler through a needle (p.305). Kablik et al characterize the properties of 6 commercially available dermal fillers (Table 1). Three of the fillers have a 12% degree of crosslinking, while the other three have a 1-2% degree of crosslinking (Restylane, Perlane, and Juvéderm 30 HV). The products having a lower degree of crosslinking also have a higher HA gel concentration of 14.4 mg/mL or 15 mg/mL. With a total HA concentration of 20-24 mg/mL, the products have about 5-9.6 mg/mL fluid HA, equivalent to 25%-40% non-crosslinked HA. The products having a higher degree of crosslinking contain about 1-2% non-crosslinked HA. In clinical studies, Restylane/Perlane and Juvéderm 30 HV showed duration of effect of 6 months in the majority of patients (p.310). These effects are postulated to be due to the products’ similar concentration and percent crosslinking. Based on these factors the artisan can design a product for optimal beneficial effect. In view of the teachings of Kablik one of ordinary skill in the art can adjust the weight ratio between water soluble HA and said polymer within said composition as in claim 1, solubility as in claims 9 and 13, concentration and solubility as in claim 11, extrusion force as in claims 16, 27, composition wherein an unmodified chain as in part (b) in claim 26, and concentration as in claim 29 for obtaining a product with optimal properties for the applications taught in the prior art.
MPEP 2141 states, "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. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. 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."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, HA chains having the molecular weight, degree of crosslinking and the crosslinking agents is known in the art for use as dermal fillers (Meunier et al), and Kablik et al teaches that the particular use of hyaluronic acid-based dermal fillers is based on several physical parameters including molecular weight, modification and crosslinking, concentration, modulus, swelling, particle size and extrusion force.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. Product improvement is the motivation. One of ordinary skill in the art will look for other HA based dermal fillers with ideal properties as alternatives in view of Meunier and Kablik.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains Terminal Disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, 9, 11, 13, 16, 26-27, 29-32 and 34 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,939,409 (‘409) in view of Meunier et al (WO 2020/003298 A1; cited in IDS filed 10/30/2024) and further in view of Kablik et al (Dermatologic Surgery, 2009, 35, 302-212; cited in IDS filed 10/30/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Claim 1 is drawn to a composition comprising a polymer comprising a first HA chain or a derivative thereof and a second HA chain or a derivative thereof, wherein the first HA chain and the second HA chain are crosslinked via one or more linkers which comprise an unsaturated moiety or a derivative thereof bound to a tetrazine moiety or a derivative thereof, wherein the crosslinking degree is between 0.6 and 4%, and wherein the weight ratio between water soluble HA and said polymer within said composition is less than 10%. Independent claim 26 is drawn to the same composition as in claim 1 with the composition comprising an unmodified HA chain characterized by an average molecular weight between 300 kDa and 4000kDa and wherein the composition is characterized by a phase angle up to 10o.
Dependent claims 2-5, 9, 11, 13, 16, 27, 29-32 and 34 recite limitations drawn to the type of linkers, tetrazine moiety linked to the HA chain via an amide bond, average molecular weight of HA, water solubility, concentration of the polymer and soluble HA, percentage of unmodified HA, extrusion force, and elastic modulus.
Claims 1-9 of ‘409 is drawn to a polymer having the claimed crosslinking agents between a first and second HA chain, degree of crosslinking, phase angle, elastic modulus, concentration, percentage of non-crosslinked HA. There is overlap of the structural features, properties, concentrations, etc.
Claims 1-9 of ‘409 differ from the instant claims in that the instant claims include an addition limitation wherein the weight ratio between water soluble HA and said polymer within said composition is less than 10%.
The teachings of the secondary references are set forth above.
It would have been obvious to one of ordinary skill in the art before the filing date of the instant invention to arrive at the claimed polymer composition in view of ‘409 and the secondary references.
In the instant case ‘409 teaches the polymer applicant claims. Although the claims of '409 are not expressly drawn to a polymer composition wherein the weight ratio between water soluble HA and said polymer within said composition is less than 10%, one of ordinary skill in the art would readily recognize that the claimed polymer composition can be arrived at in view of '409 and the secondary references with a reasonable expectation of success. Once the general polymer composition has been shown to be old, the burden is on the applicant to present reason or authority for believing that the claimed polymer composition is not obvious. Product improvement is the motivation. One of ordinary skill in the art will look for other HA based dermal fillers with ideal properties as alternatives to those taught by Meunier.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains Terminal Disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, 9, 11, 13, 16, 26-27, 29-32 and 34 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of copending Application No. 18/438,500 (‘500). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Claim 1 is drawn to a composition comprising a polymer comprising a first HA chain or a derivative thereof and a second HA chain or a derivative thereof, wherein the first HA chain and the second HA chain are crosslinked via one or more linkers which comprise an unsaturated moiety or a derivative thereof bound to a tetrazine moiety or a derivative thereof, wherein the crosslinking degree is between 0.6 and 4%, and wherein the weight ratio between water soluble HA and said polymer within said composition is less than 10%. Independent claim 26 is drawn to the same composition as in claim 1 with the composition comprising an unmodified HA chain characterized by an average molecular weight between 300 kDa and 4000kDa and wherein the composition is characterized by a phase angle up to 10o. Dependent claims 2-5, 9, 11, 13, 16, 27, 29-32 and 34 recite limitations drawn to the type of linkers, tetrazine moiety linked to the HA chain via an amide bond, average molecular weight of HA, water solubility, concentration of the polymer and soluble HA, percentage of unmodified HA, extrusion force, and elastic modulus.
Claim 1 of ‘500 is drawn to a polymer the structural features of which overlap with the polymer of the instant invention. Dependent claims 2-12 recite limitations regarding crosslinking agent, molecular weight, contact angle, elastic modulus, concentrations, and additional agents. Independent claim 13 is drawn to a kit comprising the polymer with a modification degree between 0.2 to 4%, the same structural moieties as in the instant polymer, phase angle and elastic modulus and concentration.
The copending claims of ‘500 differ from the instant claims in that the instant claims are drawn to polymer wherein the weight ratio between water soluble HA and said polymer within said composition is less than 10%.
The teachings of the secondary references are set forth above.
It would have been obvious to one of ordinary skill in the art before the filing date of the instant invention to arrive at the claimed polymer composition in view of ‘500 and the secondary references.
In the instant case ‘500 teaches the polymer applicant claims. Although the claims of 500 are not expressly drawn to a polymer composition wherein the weight ratio between water soluble HA and said polymer within said composition is less than 10%, one of ordinary skill in the art would readily recognize that the claimed polymer composition can be arrived at in view of '500 and the secondary references with a reasonable expectation of success. Once the general polymer composition has been shown to be old, the burden is on the applicant to present reason or authority for believing that the claimed polymer composition is not obvious. Product improvement is the motivation. One of ordinary skill in the art will look for other HA based dermal fillers with ideal properties as alternatives to those taught by Meunier.
One of ordinary skill in the art would have reasonably expected that the instant polymer composition would have same or substantially similar beneficial effects and usefulness in as dermal filler based on the reasonable expectation that structurally similar species usually have similar properties. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also Deuel, 51 F.3d at 1558, 34 USPQ2d at 1214, and if the claimed invention and the structurally similar prior art species share any useful property, that will generally be sufficient to motivate an artisan of ordinary skill to make the claimed species. In fact, similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904, as noted in MPEP 2144.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
1. Elected claims 1-5, 9, 11, 13, 16, 26-27, 29-32 and 34 (Group I) are rejected.
2. Group II, claims 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
3. Claims 6-8, 12, 14-15, 19-25, 28, 33, and 35-44 have been canceled.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693
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