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 .
Claims 1-3 are pending and examined on the merits.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
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.
Claims 1-3 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.
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 1, step (6), line 2, recites the broad recitation “suspension agent”, and the claim also recites – in parenthesis directly after – “(sodium carboxymethyl cellulose)” 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. Namely, whether the species only is intended or the entire genus of suspension agents. If the former, the claim should be positively amended the species only thereto. If the latter, the genus suspension agent retained and the species deleted and incorporated into dependent (New) claim 4. to e.g. The method of claim 1, wherein the suspension agent is sodium carboxymethyl cellulose.
Claim Rejections - 35 USC § 103 - Obviousness
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) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2011/119468 (Allergen, 09/11/2011).
Inventive Concept: As applicant found/described (see instant abstract), WO ‘468 equally found that the combination of EDC/NHS with NHS as the activator and EDC as the linking agent between HA molecules such as that claimed, sodium hyaluronate (NaHA), and proteins (e.g. collagen, elastin), for use in hydrogels as fillers (like applicant); showed improved results (see WO ‘468 para 61):
[0061] [ ] Taken together, these data suggest that the resulting gels from EDC/NHS mediated cross-linking have higher elasticity and hardness compared to BDDE-crosslinked hydrogel. Accordingly, EDC/NHS cross-linked HA and HA-proteins have improved properties suitable for soft tissue augmentation, such as, for example, dermal filling.
; wherein the HA-proteins refers to e.g. collagen, elastin (see WO ‘948 para 30):
[0030] [ ] In various embodiments, hydrogels of the present description include HA as a biocompatible polymer and are therefore HA-based. HA-based as used herein refers to compositions including cross-linked HA and compositions including cross-linked HA plus one or more other cross-linked polymers. In addition, HA can refer to hyaluronic acid and any of its hyaluronate salts, including, but is not limited to, sodium hyaluronate (NaHA), [ ] Hydrogels of the present description can include more than one biocompatible polymer, such as, for example [ ] proteins (e.g., elastin and collagen).
Addressing the claim steps/elements, WO ‘468 teach/suggest the following:
Step (1): mg/mL (e.g. 10mg/mL) Protein (e.g. collagen, elastin exemplified) and HA-NaHA:
WO ‘468 teach crosslinked HA hydrogels with proteins such as collagen in para 30 (cited above).
WO ‘468 teach protein (e.g. collagen, elastin) at any desired amount (para 30) and NaHA at 10mg/mL in para 31:
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Step (2): Ratio (e.g. 1:1) of NaHA:Protein(e.g. collagen, elastin) and pH 4.5-5.5.
Ratio of 1:1 is taught/suggested in WO ‘468 based on teaching that any desired ratio of HA’s (e.g. HaNA and other HA’s) is acceptable depending on the desired results (see para 40), and by extension since para 30 (cited above) teach any mixture of HA’s such as NaHA with other biocompatible polymers (e.g. collagen, elastin), such is deemed routine optimization arriving at any final ratios thereof depending on the desired final product characteristics (see para 40 by example):
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pH is taught by WO ‘468 to be “approximately” 6, rendering obvious e.g. 5.5 here as ‘approximately 6”; pH optimization of ranges through routine experimentation being a standard in the chemical arts, absent evidence of criticality (see MPEP 2144.05):
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Steps (3)-(6): General overview WO ‘468 (para 42), followed by specifics on the critical/essential steps/elements of the instantly claimed invention. WO ‘468 following standard protocols of (3) adding the cross-linking agent (paras 43-45); (4) subjecting the product to centrifugation, cleaning by phosphate buffer in a 7-9 pH solution (at e.g. para 42-46; para 23; para 18; claims 14 and 22); (5) drying (at e.g. para 42-46); (6) dissolving to obtain end product (at e.g. para 42-46).
WO ‘468 teach, generally (para 42):
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Step (3): Temperature and Time: e.g. 30 degrees Celcius for 30 hours.
WO ‘468 teach the above at para 44:
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Step (3): NHS (activating agent):EDC(cross-linking agent) ratio: e.g. 1:1.
WO ‘468 teach the above, a 1:1 ratio of NHS:EDC, per para 43
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Step (4): see WO ‘468 at e.g. para 42-46; para 23; para 18; claims 14 and 22, as directed to subjecting the product to standard cleaning steps/elements employing phosphate buffer in a 7-9 pH solution.
Step (5): see WO ‘468 at e.g. para 42-46 as to drying the cleaned product.
Step (6): see WO ‘468 at e.g. para 42-46, as drawn to dissolving the final end product by routinely optimizable steps/means of dissolving composite/hydrogel end products of all impurities other than the desired end product and is deemed to render prima facie obvious simple selection of a finite number of other agents employed with the state of the art to carry out the same, absent evidence of criticality (MPEP 2144.05):
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Claim 2 is drawn to animal type collage I or III as the source, as taught by WO ‘468 at para 4 (bovine as collagen source; para 30 (protein as collagen).
Claim 3 is drawn to NaHA being bacterial sourced as taught in WO ‘468 para 37:
“[0037] The present description also provides methods for making hydrogels. The methods can include providing at least one cross-linkable biocompatible polymer, such as HA. The initial step of providing raw HA material can be in the form of dry HA fibers or powder. The raw HA material may be HA, its salts and/or mixtures thereof. The HA material can comprise, for example, NaHA fibers or powder of bacterial-sourced aHA.”
; while the final limitation is to NaHA being 100,000 to 3 million Da, for which WO ‘468 puts no limit on HA/NaHA size, per para 40, the vast size range claimed here is deemed merely a matter of selection depending on the desired size of the end product (routinely optimizable to arrive at alternative ranges/concentrations absent a showing of criticality; MPEP 2144.05):
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Thus, the inventive concept and the instantly claimed invention scope are deemed prima facie obvious over the teaching/suggestions of WO ‘468 (Allergon) with ranges/concentrations therein being routinely optimizable parameters absent a showing of criticality (MPEP 2144.05).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAURY A AUDET/Primary Examiner, Art Unit 1654
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