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 .
The amendment filed 26 May 2026 has been received, entered and considered. The following information has been made of record in the instant amendment:
1. No Claims have been canceled.
2. No new Claims have been added.
3. Claims 1-8, and 10-12 have been amended.
4. Remarks drawn to claim objections and rejections under 35 USC 103 and double patenting.
The objection to claims 1-8 and 10-12 has been overcome by amendment.
Claims 1-12 are pending in the case. Group II, claim 9 has been withdrawn form further consideration as being drawn to a non-elected invention. Claims 1-8 and 10-12 are under examination.
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; of record).
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 (see also claim 15 at page 16 of Rosa; component recited in claim 1, 3, 7). 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.
Response to Applicant’s Remarks
Applicant has traversed the rejection of claims 1-8 and 10-12 under 35 USC 103 arguing that De Rosa primarily describes joint viscosupplementation and other biomedical applications, not specific dermo-aesthetic formulations with the claimed parameters. De Rosa is silent with regard to an extrusion force not exceeding 40N, as presently claimed, nor does it teach it or suggest a residence time of at least 9 weeks. The Examiner has taken the position that one of ordinary skill in the art can adjust the molecular weight of the two hyaluronic acids and their amounts to arrive at a composition having a suitable viscosity and extrusion force not exceeding 40N. This is a conclusory statement. No evidence has been provided that these specific parameters were known or predictable in the art. The mere presence of similar components does not render the specific claimed functional parameters obvious to one of ordinary skill in the art.
The Examiner also asserts that chondroitin and HA used have the molecular weights in the claimed range, and therefore the composition would have the claimed residence time. This is assertion of inherent property without evidentiary support. De Rosa does not measure or disclose in vivo residence time of its composition.
Forsey describes the use of phospholipids in a human cartilage damage model. This is a different context from the dermo-aesthetic use presently claimed. The motivation to combine De Rosa with Forsey is not applicable to the claimed injectable dermo-aesthetic formulation.
The current specification discloses that the half-life of hyaluronic acid differs across various tissues: 3-5 minutes in circulation, less than a day in the skin, and 1 to 3 weeks in cartilage tissue (Specification, page 2). This demonstrates the behavior of HA in the dermis is different from its behavior in the cartilage. Teachings related to articular applications cannot be simply transferred and extrapolated to dermal applications and residence time achieved in the dermis cannot be predicted from compositions designed for joint viscosupplementation. For the above reasons withdrawal of the rejection is requested. Remarks; pages 6-8).
Applicant’s arguments are not persuasive. Claim 1 and dependents thereof are drawn to an aqueous formulation of at least one high molecular weight linear hyaluronic acid or hyaluronate and at least one low molecular weight linear hyaluronic acid or hyaluronate, each having a specific average molecular weight range, or non-sulphated chondroitin, characterized by an extrusion force not exceeding 40N and a residence time in vivo of not less than 9 weeks.
Rosa teaches an aqueous formulation comprising one high molecular weight HA and one low molecular weight HA, both in the claimed molecular weight range, and also chondroitin in combination with high molecular weight HA. The specific dermo-aesthetic formulation as recited in claim1 is intended use and is not given patentable weight. Rosa teaches that the rheological properties of solutions of low molecular weight and high molecular weight HA is determined by the simultaneous presence of the two HA’s, molecular weight of two species of HA, and relative proportions (Rosa, page 2, line 19 through page 3, line 26). This is suggestion to the artisan that a formulation comprising the two HA’s can be prepared by adjusting the molecular weight of the two hyaluronic acids and their amounts to arrive at a composition having a suitable viscosity and extrusion force not exceeding 40N.
Rosa may not have measured the residence time. However, the residence time of an aqueous formulation of a combination of the two HA’s, including phospholipids and chondroitin, can be screened by one of ordinary skill in the art. Applicant refers to different residence times as known in the prior art, and that residence time of HA in skin is 2-4 days according to Balaz and Larsen reference, and less than a day in skin according to Romagnoli reference. This means that one of ordinary skill in the art knows this and can choose molecular weight and concentrations having suitable extrusion force, viscosity, and residence time. This also means that the combination having the residence time is there and can be determined by routine experimentation. This is what applicant has also done.
The motivation to combine De Rosa with Forsey is applicable to the claimed composition. It does not have to be for dermo-aesthetic application as recited since it is intended use.
Applicant has argued that the residence time of HA in various tissues varies, and refers to different residence times as known in the prior art. According to the references at page 2 of the specification, the residence time of HA is very low irrespective of molecular weight. According to the prior art applicant’s combination of HA should also have a low residence time. Applicant has not shown what has been done differently to arrive at the claimed composition having a residence time of not less than 9 weeks in vivo other than using a combination of a particular range of low and high molecular weight HA as an aqueous solution and extrusion force not exceeding 40N.
The combined teachings of the cited prior art render the instant claims obvious. The rejection is maintained.
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.
Response to Applicant’s Remarks
Applicant has traversed the rejection of claims 1-8 and 10-12 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; of record) arguing that the presently claimed invention is directed to an injectable dermo-aesthetic formulation for intradermal injection characterized by special functional parameters: an extrusion force not exceeding 40N and residence time in vivo of not less than 9 weeks.
Claim 1 of ‘303 recites a viscosity not exceeding 30 mPa.s, with specific molecular weight ranges, but does not recite extrusion force not exceeding 40N, nor a residence time in vivo of not less than 9 weeks, nor does it specify use for intradermal injection in dermo-aesthetic applications. Claim 1 of ‘944 recites a composition comprising non-sulphated chondroitin and hyaluronic acid, but does not recite specific molecular weight ranges, nor viscosity, nor extrusion force, nor a residence time in vivo of not less than 9 weeks, nor does it specify use for intradermal injection in dermo-aesthetic applications. The Examiner has combined the reference patents with the teachings of De Rosa and Forsey to bridge the gaps.
As argued above, this combination is not appropriate. De Rosa does not describe functional parameters claimed, and Forsey describes the use of phospholipids in an entirely different context which is not applicable to intradermal dermo-aesthetic formulations. For the reasons discussed above withdrawal of the rejection is requested (Remarks-pages 8-9).
Applicant’s arguments are not persuasive. The Examiner’s response above also applies here, and for same reasons the obviousness-type double patenting rejection of record is also being maintained.
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.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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