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 without traverse of Group I claims 1-8 and 10-12 in the reply filed on 26 November 2025 is acknowledged. The election/restriction requirement is deemed proper and is therefore made FINAL. An Action on the merits of claims 1-8 and 10-12 is contained herein below.
Group II Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.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/EP2020/086691 filed 12/17/2020. This application claims foreign priority to ITALY IT102019000024208 filed 12/17/2019, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document has been filed in the instant application.
Claim Objections
Claims 1-8 and 10-12 are objected to because of the following informalities: Claim 1 and dependents are drawn to a product. An independent product claim should the term ‘A(n) at the beginning followed by the product, and the dependent claims should begin with the term ‘The” followed by limitations. Claim 8 which is a dependent claim, should recite ‘The formulation’ instead of ‘A formulation’. Appropriate correction is required.
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.
Claim(s) 1-8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over De Rosa et al (WO 2012/032151 A2; Rosa; of record) in view of Forsey et al (Biomaterials, 2006, 27, 4581-4590).
Rosa teaches a formulation comprising an aqueous solution of one high molecular weight hyaluronic acid (MW 1.4 x 106 Da which is 1400 kDa) and one low molecular weight hyaluronic acid (MW 3.3 x 104 Da which is 33 kDa) to get a complex and its viscosity (page 6, line 12 through page 7, line 14). Table 4 at page 11 shows the viscosity of the mixture without the thermal cycle as in Example 1 (components and molecular weights as in claims 1, 4-5, 10 and 12). The composition is 2% w/v (see line below Table 1 at page 7; as in claim 3).
Example 7 at page 12 discloses chondroitin in combination with high molecular weight HA (component recited in claim 1, 3, 7; see also claim 15 at page 16). The solution is prepared as a 2wt% in water and has low dynamic viscosity (page 13, lines 4-7; as in claim 3). The uses of the compositions taught by Rosa also include the combination of high molecular weight HA and chondroitin (see claim 17 at page 16).
Even though Rosa does not expressly teach an extrusion force not exceeding 40N and a residence time of not less than 9 weeks as in claim 1, one of ordinary skill in the art can adjust the molecular weight of the two hyaluronic acids and their amounts to arrive at composition having a suitable viscosity and extrusion force that does not exceed 40N as in claim 1 since Rosa teaches that these compositions are used in biomedical applications like biorevitalization of skin by intradermal injection of HA and others (page 5, lines 22-28). Doing so would make it easy for injecting the composition during the various applications without any complications. Since the components used are hyaluronic acids having the molecular weights in the claimed range and chondroitin the composition should have the residence time as in claim 1. It would be obvious to the artisan to use at least two different high molecular weight hyaluronic acids or hyaluronates as in claim 2, and use the hyaluronic acids or hyaluronates having the molecular weights and ratios as in claims 6-7 and 11 in order to look for compositions having the claimed properties for use in the applications taught in the prior art.
Rosa et al does not teach a composition which has at least one high molecular weight HA in combination which further comprises a phospholipid as in claim 9.
Forsey et al a combination of phospholipids and HA produced 46-51% reduced friction in a damaged human cartilage model (Abstract; page 4582, left col., last para; page 4588, left col. second full para; page 4589, Conclusion; limitation of claim 8). In view of this teaching one of ordinary skill in the art will use phospholipid as a component in the composition of Rosa which is also used as a viscosupplement (page 14, Example 9).
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, a composition comprising a low molecular weight HA and high molecular weight HA having a viscosity in a range suitable for injection is known in the art to be used in biomedical applications. Forsey teaches that phospholipid in combination with HA reduces friction. Thus, it is obvious to arrive at the claimed composition in view of the combined teachings of the prior art.
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. The artisan would be motivated to make the claimed composition since Rosa teaches that the combination of low- and high-molecular weight HA according to its invention are stable over time, attesting to the maintenance of rheological characteristics and can be easily obtained by mixing aqueous solutions of desired molecular weights (page 4, line 30 through page 5, line 3). According to Rosa viscosity of the HA solution is very important in the medical field (page 2, lines 19-22). Therefore, using a HA solution that has a stable viscosity is important.
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 1-8 and 10-12 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,878,030 (‘030) and over claim 1 of U.S. Patent No. 10,206,944 (‘944) in view of De Rosa et al (WO 2012/032151 A2; Rosa; of record) and Forsey et al (Biomaterials, 2006, 27, 4581-4590). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Claim 1 is drawn to a formulation comprising aqueous solutions of at least one high molecular weight HA or hyaluronates not subjected to crosslinking and having a molecular weight ranging from 1000-6000kDa and at least one low molecular weight HA or hyaluronate having non crosslinking and having a molecular weight range of 10 to 300kDa or non-sulphated chondroitin, characterized by an extrusion force not exceeding 40N and a residence time in vivo of not less than 9 weeks. Dependent claims 2-9 and 10-12 recite limitations drawn to use of two different high molecular weight HA, percentage of high molecular HA and non-sulphated chondroitin, molecular weight range for low molecular weight HA, ratio of low molecular weight HA or non-sulphated chondroitin to high molecular weight HA, phospholipid as a component.
Claim 1 of ‘030 is drawn to a formulation comprising a low molecular weight and high molecular weight HA with a viscosity not exceeding 30mPa, with the low molecular weight HA or chondroitin having a molecular weight ranging from 1.104 to 1.105 Da and the high molecular weight HA having an average molecular weight of at least 5 times higher than that of low molecular weight HA.
Claim 1 of ‘944 is drawn to a composition comprising non-sulphated chondroitin and hyaluronic acid.
Claims 1 of ‘030 and ‘944 differ from the instant claims in that the instant claims employ a particular range of molecular weights for both HA’s and do not recite a value for viscosity, whereas ‘030 recites a viscosity of not exceeding 30mPs, and ‘944 does not recite a molecular weight range for HA and does not recite a viscosity.
The teachings of Rosa and Forsey are set forth above. Rosa teaches the use of high molecular weight HA in the example cited which is about four times higher than the low molecular weight HA. Rosa has also disclosed examples using other molecular weights for both HA’s.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to arrive at the claimed compositions in view of the cited prior art.
The use of known components in compositions taught in the prior art is not seen to render the instantly claimed composition unobvious over the art. One of ordinary skill in the art would modify the teachings of the prior art to arrive at the claimed invention in order to look for compositions that have the ideal properties for the uses taught in the prior art.
Conclusion
1. Elected claims 1-8 and 10-12 (Group I) are rejected.
2. Group II Claim 9 is 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.
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/GANAPATHY KRISHNAN/ Primary Examiner, Art Unit 1693