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 .
Election/Restrictions
Applicant’s election of Group (i) in the reply filed on 11/18/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election of
(i) L-cysteine as the elected antioxidant species;
(ii) Polysorbate 80 as the elected surfactant species, and
(iii) propylene glycol, water, and a combination of sodium acetate and glacial acetic acid as the elected pharmaceutically acceptable excipients, in the reply filed on 11/18/2025 is acknowledged and maintained.
Claims 8, 13, and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim.
Expansion of Election of Species Requirement
A reasonable and comprehensive search conducted by the Examiner determined that the prior art at the time of the present invention was such that it did anticipate or render obvious the elected species. In light of this discovery, the search is expanded to BHT as the expanded antioxidant and tartaric acid and water as the expanded excipients. However, the search has not been expanded to the full scope of antioxidant and pharmaceutically acceptable excipients.
Priority
This application is a filing under 35 U.S.C. § 371 of International Application No. PCT/IN2021/050771, filed August 11, 2021, which claims priority to Indian Patent Application No. 202021034467, filed August 11, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/01/2026 has been considered by the examiner.
Claim Status
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on July 01, 2026.
Claims 1-12 are pending. Claim 8 is withdrawn. Claims 13- and 14 are canceled. Claims 1-7 and 9-12 are examined in accordance to the elected species and the expanded species.
Action Summary
Objection to claim 9 is withdrawn in light of the amendment of claim 9.
Claims 1-3, 5-7, and 12 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sakaguchi et al (JPH11236331A), are withdrawn in light of the amendment of claim 1.
Claims 1-3, 5-7, 10, and 12 rejected under 35 U.S.C. 103 as being unpatentable over Sakaguchi et al (JPH11236331A), are withdrawn in light of the amendment to claim 1.
Claims 1-7, 9, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Sakaguchi et al (JPH11236331A) in view of Savarese et al (US9,220,700B2) and Koneru et al (US10,028,921B1), are withdrawn in light of the amendment to claim 1.
New Claim Objections
Claim 1 is objected to because of the following informalities. The phrase “pharmaceutically acceptable excipients thereof” is unclear because the term “thereof” lacks a clear referent and appears unnecessary. Appropriate correction is required. For example, Applicant may amend the claim to recite “wherein the pharmaceutically acceptable excipient comprising propylene glycol, sodium acetate, glacial acetic acid, and water,” or equivalent language, without introducing new matter.
Additionally, sodium acetate is recited twice in claim 1. The duplicate recitation appears to be inadvertent and should be deleted for clarity and consistency. Appropriate correction is required, provided no new matter is introduced.
New Claim Rejections - 35 USC § 112
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 3. 4, 6, 9 and 10 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.
Independent claim 1 now positively recites that (i) the antioxidant comprises L-cysteine, (ii) the surfactant comprises polysorbate 80, and (iii) pharmaceutically excipients comprise propylene glycol, sodium acetate, glacial acetic acid, and water.
Because the amendment to independent claim 1 now positively require L-cysteine polysorbate 80, propylene glycol, sodium acetate, glacial acetic acid, and water, the dependent claim no longer clearly indicate whether they are intended to further limit the independent claim or instead redefine limitations already recited therein. As a result, the scope of the dependent claims in uncertain.
Specifically claim 3 recites that “the antioxidant comprises L-cysteine, thioglycerols, glutathione, ascorbic acid … or combinations thereof.” Since claim 1 already requires that the antioxidant comprises L-cysteine, it is unclear whether claim 1 merely requires the antioxidant to further comprise one or more additional antioxidants while retaining L-cysteine, or instead redefines the antioxidant of claim 1 as any one of the listed antioxidants, including embodiments that would omit L-cysteine. Consequently, the metes and bounds of claim 3 cannot be determined with reasonably certainty.
Similarly, claim 4 recites that “the antioxidant is cysteine, monothioglycerol, or combination thereof.” Because claim 1 already requires an antioxidant comprising L-cysteine, it is unclear whether claim 4 encompasses embodiments in which monothioglycerol alone is the antioxidant or whether claim 4 requires L-cysteine to remain present together with monothioglycerol. Thus, the scope of claim 4 is indefinite.
Likewise, claim 6 recites that “the surfactant comprises polysorbate 80, polyoxyl 35 castor oil, mixed micelles comprising glycocholic acid, and lecithin and combinations thereof,” Since claim 1 already requires the surfactant to comprise polysorbate 80, it is unclear whether claim 6 merely requires the surfactant to further comprise one or more additional surfactants while retaining polysorbate 80, or instead redefines the surfactant as any on of the recited surfactants, including embodiments that would omit polysorbate 80. Accordingly, the scope of claims 6 is not reasonably certain.
Claim 9 recites “the buffering agent,” and claim 10 recites “the co-solvent.” However, the patent claim does not recite either a buffering agent or a co-solvent. Rather, the parent claim 1 recites sodium acetate, glacial acetic acid, and propylene glycol as pharmaceutically acceptable excipients. Accordingly, it is unclear whether claims 9 and 10 introduce new formulation components, merely identify functional characteristic of the excipients already required by claim 1, or otherwise redefine those excipients. Because the relationship between these newly introduced claim elements and the limitations of claim 1 is unclear, the metes and bounds of claims 9 and 9 cannot be determined with reasonable uncertainty. While lack of antecedent basis according to MEPE 2173.05(e) is not automatically indefinite, in this case, it creates substantive uncertainty because the “buffering agent” and the “co-solvent” are newly introduced claim elements whose relationship to the previous recited excipient in claim 1 is unclear.
New 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 non-obviousness.
Claims 1-7, and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sakaguchi et al (JPH11236331A) in view of Riebesehl et al (US 6,686,365 B2) and Koneru et al (US10,028,921B1).
Sakaguchi teaches a storage stable vitamin A solubilization preparation containing vitamins A having vitamin A activity, a surfactant for solubilizing the vitamins A in an aqueous solution, and a stabilizer for stably presenting the vitamins A in the aqueous solution, wherein the average particle diameter of the vitamins A in the aqueous solution is 50 nm or less. (See claim 1.) Moreover, Sakaguchi teaches a preferred vitamin A solubilized preparation was prepared by mixing aqueous and oil phases containing the following components: Aqueous phase: Tartaric acid (a stabilizer): 1 g, Purified water 1500 g (a specific concept of "pharmaceutically acceptable excipients"); Oil phase: Vitamin A palmitate: 1 g, Polysorbate 80 (a surfactant): 161.15 g, BHT (an antioxidant): 0.24 g, Cholecalciferol (a vitamin D agent): 0.01 g, Tocopherol acetate (a vitamin E agent): 36 g, phytonadione (a vitamin K agent): 1.6 g.
First, each constituent material of the oil phase was placed in a glass beaker having a capacity of 500 ml and stirred using a magnetic stirrer Additionally, tartaric acid and water for injection were added to a 3L stainless steel beaker to dissolve it completely. Next, while stirring the tartaric acid solution, the previously prepared oil phase was gradually added to obtain a transparent mixed solution. Further, water for injection was added to the mixed solution to bring the total volume to 2L, thereby preparing a vitamin A solubilized preparation. These results indicate that the vitamin A solubilized preparations of Examples 1 to 4 hardly damage the vitamin A compounds even in aqueous solution and maintains their activity Furthermore, since almost no change in average particle size was observed over time, it can be concluded that the solubilized state is maintained stably over a long period of time. (See Example 2.)
The amount of phytonadione is 1.6 g in the 2 L total volume. Since the total final volume is 2 L, the amount of phytonadione is (1.6 g X 1000 mg) / (2L X 1000 ml) = 0.8 mg/ml of the total preparation. The amount of phytonadione is 0.8 mg/ml of the total preparation.The amount of BHT (antioxidant) is 0.24 g in the 2 L total volume. Since the total final volume is 2 L, the amount of BHT is (0.24 g X 1000 mg) / (2 L X 1000 ml) = 0.12 mg/ml of the preparation. The amount of BHT (antioxidant) is 0.12 mg/ml of the preparation. The amount of polysorbate 80 (surfactant) is 161.15 g in the 2 L total volume. Since the total final volume is 2 L, the amount of polysorbate 80 is (161.15 g X 1000 mg) / (2 L X 1000 ml) = 80.58 mg/ml of the preparation. The amount of polysorbate 80 (surfactant) is 80.58 mg/ml of the preparation.
However, Sakaguchi does not teach a mixture of propylene glycol and water as recited in claim 10. However, Sakaguchi teaches a Soluble Preparation of vitamin A where each aqueous phase having the following composition and an oil phase were mixed to prepare a vitamin A solubilized preparation.Aqueous phase Propylene glycol: 400 g Sodium metaphosphate (stabilizer): 5 g Purified water: 395 g. Oil phase Vitamin A acetate: 50 g Polyoxyethylene hydrogenated castor oil 60 (surfactant): 150g. First, propylene glycol and an aqueous solution of sodium metaphosphate dissolved in purified water were mixed in a stainless-steel beaker having a capacity of 2 L to prepare an aqueous phase. (See Example 1.)
Sakaguchi does not expressly teach the antioxidant is L-cysteine and pH from about 3.5 to 7. Moreover, Sakaguchi does not teach a buffering agent comprising sodium acetate and glacial acetic acid in the amount of 0.05 mg to 1 mg/ml of the formulation. However, Sakaguchi teaches as a conventional technique for stabilizing vitamin A, a method using an antioxidant is known. For example, a method of adding a fat-soluble antioxidant such as dibutyl hydroxytoluene (BHT) and butyl hydroxyanisole (BHA) and a water-soluble antioxidant such as ascorbic acid, hydroquinone and cysteine. (See paragraph [0004].) Sakaguchi also teaches the preparation may use an electrolyte component as additive, a pH adjuster, and various buffer solutions. (See last paragraph of page 5.)
Riebesehl expressly addresses the need for a pharmaceutically stable liquid pemetrexed formulation having both color stability and acceptable shelf-life stability with regard to retaining the solution dosage form and avoiding unacceptable degradation to undesired related substances. Additionally, the formulations can be diluted to the desired administration concentration by the health care provider. Finally, the formulations provided herein do not require the addition of any preservative, other than the antioxidant, in order to retain the desired concentration and stability. (See lines 49-59 of column 1.) Riebesehl further teaches a pharmaceutical composition comprising:
a) pemetrexed;
b) at least one antioxidant selected from the group consisting of
i) monothioglycerol,
ii) L-cysteine,
iii) thioglycolic acid; and
c) a pharmaceutically acceptable excipient.
The three antioxidants are uniquely effective for the claimed formulation. Surprisingly, common antioxidants, such as sodium metabisulfite, ascorbic acid, sodium EDTA, monoethanolamine gentisate, sodium formaldehyde sulfoxylate, sodium bisulfite, did not provide the desired formulation characteristics. (See lines 60-67 of column 1 bridging lines 1-7 of column 2.) The whole column 2 of Riebesehl explains that the antioxidant properties of L-cysteine, monothioglycerol, and thioglycolic acid are concentration-dependent.
Koneru teaches phytonadione Injectable Emulsion, USP, is a yellow, sterile, aqueous colloidal solution of vitamin K1, with a pH of 3.5 to 7.0. It is available for injection by the intravenous, intramuscular, and subcutaneous route. Each 0.5 mL contains 1 mg phytonadione (Vitamin K1), 10 mg polysorbate 80, 10.4 mg propylene glycol, 0.17 mg sodium acetate anhydrous, and 0.00002 mL glacial acetic acid. Additional glacial acetic acid or sodium acetate anhydrous may have been added to adjust pH to meet USP limits of 3.5 to 7.0. (See lines 50-60 of column 1.)
It would have been prima facie obvious to one of ordinary skill at the time the invention was filed in the art to modify the storage-stable phytonadione solubilized preparation of Sakaguchi by (i) selecting L-cysteine as the antioxidant taught by Riebesehl and (ii) incorporating the sodium acetate/glacial acetic acid buffering system taught by Koneru to obtain Applicant claimed injectable formulation. One would have been motivated to do so because Sakaguchi recognizes that antioxidants are conventional technique for stabilizing oxidation-sensitive vitamin formulation and expressly identifies cysteine among suitable antioxidants. Sakaguchi further teaches that the formulation may include electrolyte component, pH adjusters, and various buffer solutions. Riebesehl addresses the same technical problem of obtaining a pharmaceutical stable, ready-to-use liquid injectable formulation having improved storage stability and teaches that, among numerous antioxidants evaluated, L-cysteine and monothioglycerol uniquely provide the desired and reduced degradation of the active ingredient during storage. (See column 1.) Riebesehl further teaches that the antioxidant concentration is optimized to achieve the desired stability and provides preferred concentration ranges for L-Cysteine, thereby recognizing that antioxidant concentration affects formulation stability. (See column 2.) Koneru teaches a phytonadione injectable emulsion containing polysorbate 80, propylene glycol, sodium acetate, glacial acetic acid, and a pH of about 3.5 to 7.0, thereby providing a known buffering system suitable for injectable phytonadione formulations.
Accordingly, one of ordinary skill in the art would have reasonably expected that substituting the conventional antioxidant BHT of Sagaguchi with the pharmaceutically recognized antioxidant L-cysteine taught by Riebesehl, while incorporating the sodium acetate/glacial acetic acid buffering system taught by Koneru, would have yielded a pharmaceutically acceptable storage-stable injectable phytonadione formulation because each reference is directed to solving the same common problem of oxidative degradation and storage stability in liquid injectable pharmaceutical formulations through the routine selection of formulation excipients. The substitution merely involves the use of one known antioxidant for another known antioxidant performing the same function within the formulation and the use of a known injectable buffering system to maintain formulation pH, both of with constitute routine formulation optimization well within the level of ordinary skill in the art.
Applicant’s specification further confirms that the degree of oxidative stability is dependent upon the concentration of L-cysteine, expressly concluding that increasing antioxidant concentration provides better protective action and minimizes oxidative degradation products. Thus, the specification itself demonstrates that optimization of antioxidant concentration affects the degree of stability obtained. Riebesehl likewise teaches optimization of L-cysteine concentration to achieve desired storage stability. (See columns 1 and 2.) Because amended claim 1 is not limited to any concentration of L-cysteine, Applicant’s comparative data are not commensurate in scope with the full breadth of the amended claim and therefore are of diminished probative value in rebutting the prima facie case of obviousness.
With respect to the claimed sodium acetate and glacial acetic acid being present in amount from about 0.05 mg to 1 mg per ml of the formulation. The 0.17 sodium acetate anhydrous, and 0.00002 mL glacial acetic give a buffer solution in an amount of 850 mg/ml. However, for a volume of 2 L or 2000 ml, the 850 mg/ml in a 2 L volume would give 0.43 mg/ml of the buffer solution, meeting the limitation of claim 9.
Accordingly, Sakaguchi does not specifically teach the stability of the formulation when stored for six months in a sealed and sterile vial at 25°C/ 60% RH and 40°C/ 75% RH contains no more than 1.0% of individual oxidative degradation products and no more than 3.0% of total degradation products as measured by HPLC as recited in claim 12. However, said limitation is the characteristic or the property of the preparation. Since the structure recited in Sakaguchi is substantially identical to that of the claims, the claimed properties are presumed to be inherent. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Acknowledgement is made of the receipt and entry of Applicant’s argument/remarks filed on July 01, 2026. Applicant’s arguments have been considered but are not persuasive.
Applicant first argues that Sakaguchi neither teaches nor suggests each and every limitation of amended independent claim 1 and therefore the rejection based on Sakaguchi have been overcome.
This argument is not persuasive because the rejection under U.S.C 103 is based on the combined teachings of Sagaguchi, Riebesehl, and Koneru, rather than Sakaguchi alone. Obviousness does not require each reference individually disclosed every limitation. Rather, the proper inquiry is whether the combined teachings of the references would have suggested the claimed subject matter to one of ordinary skill the art at the time the invention was filed. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Applicant next argues that one of ordinary skill in the art would not have been motivated to modify Sakaguchi by specifically incorporating L-Cysteine, propylene glycol, sodium acetate, and glacial acetic acid, and that the rejection relies on impermissible hindsight reconstruction.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Specifically, Sakaguchi is directed to storage-stable injectable vitamin formulations and expressly recognizes antioxidants as conventional agents for minimizing oxidative degradation. Sakaguchi specifically identifies cysteine among suitable water-soluble antioxidants and further teaches the formulation may contain electrolyte components, pH adjusters, and various buffer solutions. Thus, Sakaguchi itself recognizes that formulation stability may be achieved through routine selection of known antioxidants and buffering systems. Riebesehl addresses the same technical problem confronted by Applicant, namely, the preparation of pharmaceutical stable, ready-to-use liquid injectable formulations exhibiting acceptable long-term storage stability, while minimizing degradation of the active ingredient. Riebesehl expressly teaches that amount numerous antioxidants evaluated L-cysteine, monothioglycerol, and thioglycolic acid provided the desired formulation characteristics, whereas several conventional antioxidants including BHT failte to provided acceptable stability. (See columns 1 and 2.) Accordingly, Riebesehl provides a clear motivation to employ L-cysteine as a pharmaceutical antioxidant to improving storage stability in liquid injectable formulations.
Applicant further argues that Sakaguchi teaches away from incorporating antioxidants because comparative formulations allegedly demonstrate superior performance in the absence of antioxidants.
This argument is not persuasive. A reference teaches away only when it criticizes, discredits, or otherwise discourage the use of antioxidants. To the contrary, Sakaguchi expressly recognizes antioxidants, including cysteine, as conventional stabilizing agents useful in pharmaceutical formulations. The mere disclosure of an embodiment lacking an antioxidant, or the existence of comparative examples, does not constitute a teaching away from the use of antioxidants where the reference otherwise recognizes such antioxidants as conventional stabilizers.
Applicant additionally argues that BHT and L-cysteine are not interchangeable because BHT is oil soluble whereas one of ordinary skill in the art would not have substituted one antioxidant for the other.
This argument is likewise not persuasive. The rejection is not predicated upon the antioxidants to possessing identical physiochemical properties. Rather, the rejection relies upon the well-recognized use of antioxidants to inhibit oxidative degradation within pharmaceutical formulations. Riebesehl specifically teaches that L-cysteine is an effective antioxidant for achieving storage-stable injectable formulations and that L-cysteine is among a limited group of antioxidants providing the desired formulation characteristics. Consequently, one of ordinary skill in the art would have reasonably expected L-cysteine to function as a suitable antioxidant in another oxidation-sensitive injectable formulation.
Applicant also argues that the addition of sodium acetate and glacial acetate acid would destabilize the formulation that one of ordinary skill in the art would therefore avoid such a modification.
These assertions constitute attorney’s arguments unsupported by objective evidence. No comparative experimental evidence has been provided establishing that incorporation of the buffering system taught by Koneru would render Sakaguchi’s formulation unsuitable for its intended purpose. Attorney argument cannot take the place of objective evidence. See in re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974).
Applicant further contends that the claimed formulation exhibits unexpected stability based upon the comparative data presented in the specification. While the data have been fully considered, they are insufficient to outweigh the prima facie case of obviousness for at least two reasons.
First, the evidence is not commensurate in scope with the amended claim 1. Applicant’s specification expressly demonstrates that the degree of oxidative stability depends upon the concentration of L-cysteine, concluding that increasing antioxidant concentration provides improved protection and minimizes oxidative degradation products. Thus, Applicant’s own disclosure establishes that the asserted improvement is concentration dependent. However, the amended claim 1 merely requires that the formulation comprises a) Phytonadione or a pharmaceutically acceptable salt thereof; b) an antioxidant, wherein the antioxidant comprises L-Cysteine; c) a surfactant, wherein the surfactant comprises polysorbate 80, d) pharmaceutically acceptable excipients thereof, wherein the pharmaceutically acceptable excipients comprise propylene glycol, sodium acetate, glacial acetic acid and sodium acetate, and water. and is not limited any concentration or preferred concentration range. Accordingly, the comparative data do not establish that the asserted stability improvement extends throughout the full scope of the amended claim.
Second Riebesehl independently recognizes that the concentration of L-cysteine and other thiol antioxidant is optimized to achieve the desired storage stability and provides preferred concentration ranges for L-cysteine in liquid injectable pharmaceutical formulations. Therefore, optimization of antioxidant concentration constitutes routine formulation optimization that would have been well within the level of ordinary skill in the pharmaceutical formulation art.
Accordingly, Applicant has not presented persuasive evidence or arguments sufficient to overcome the prima facie case of obviousness established by the combined teachings of Sakaguchi, Riebesehl, and Koneru. The rejection under 35 U.S.C. 103 is therefore maintained.
Conclusion
Claims 1-7 and 9-12 are not allowed.
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 JEAN P CORNET whose telephone number is (571)270-7669. The examiner can normally be reached Monday-Thursday from 7.00am-5.30pm.
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/JEAN P CORNET/Primary Examiner, Art Unit 1628
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