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 .
Application Status
2. Applicant’s amendment and response, submitted December 17, 2025, has been reviewed by the examiner and entered of record in the file. Claims 38, 62, 125 and 126 are amended. Claims 44, 48-50 and 58 are canceled. Claims 129-133, drawn to methods, are newly added.
3. Applicant previously elected Group II (claims 38-40, 42, 118 and 120-128), drawn to a pharmaceutical formulation. Claims 62 remains withdrawn and new claims 129-133, drawn to a method of use, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, without traverse, there being no allowable generic or linking claim.
4. Applicant previously elected the following species:
(a) the pharmaceutically acceptable alcohol: ethanol; (b) the isomer of cresol: meta-cresol; (c) the inert gas: carbon dioxide.
5. Claims 38-40, 42, 118 and 120-128 are under examination with the elected species and are the subject of this office action.
Priority
6. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
7. The disclosure of prior-filed Provisional Application No. 62/345,972 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In independent claim 38, the recited pharmaceutically acceptable formulation comprises the component dimethyl sulfoxide, which component is not described or supported in Provisional App. No. 62/345,972.
Therefore, the instant claims are afforded benefit of priority to PCT Application No. PCT/US2020/066482, filed December 21, 2020.
Previous Claim Rejections - 35 USC § 112
8. Claim 58 was previously 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 regards as the invention.
9. Claim 58 is canceled, therefore the previous indefiniteness rejection is withdrawn.
10. Claim 118 remains 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 regards as the invention.
11. Claim 118 is drawn to claim 38, and limits wherein the pharmaceutically acceptable formulation “is substantially free of one or more of impurities selected from the group consisting of Impurity A, Impurity B, Impurity C, Impurity D, and Impurity E.” However, Applicant has failed to define or set forth each of “Impurity A,” “Impurity B,” “Impurity C,” “Impurity D,” and “Impurity E” within the claim itself. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
12. Applicant has amended the specification to provide clear compound structures for each of Impurity A, Impurity B, Impurity C, Impurity D, and Impurity E in paragraphs [0128]-[0132], however as stated above, claims should not refer back to tables, structures or figures in the specification. It is recommended that Applicant copy the compound structures of Impurity A, Impurity B, Impurity C, Impurity D, and Impurity E into the claim itself. There is no limit to the length of a claim.
Previous Claim Rejections - 35 USC § 103
13. Claims 38-40, 42, 48, 58, 120, 121, 127, and 128 were previously rejected under 35 U.S.C. 103 as being unpatentable over Plachetka et al., U.S. 20030114476 A1 in view of Sutter et al. U.S. 20050203000 A1.
It is noted that the Cook et al., U.S. 20100284940 A1, reference was inadvertently previously cited in this rejection in the office action of September 17, 2025.
14. Claims 44, 49 and 122-125 were previously rejected under 35 U.S.C. 103 as being unpatentable over Plachetka et al., U.S. 20030114476 A1 in view of Sutter et al., U.S. 20050203000 A1, as applied to claims 38-40, 42, 120, 121, 127 and 128, and further in view of Cook et al., U.S. 20100284940 A1.
15. Claims 50 and 126 were previously rejected under 35 U.S.C. 103 as being unpatentable over Plachetka et al., U.S. 20030114476 A1 in view of Sutter et al., U.S. 20050203000 A1, and in view of Cook et al., U.S. 20100284940 A1, and further in view of Levine et al., Biochemistry 1996.
16. In view of Applicant’s amendments and cancellations to the claims, the previous obviousness rejections are withdrawn. However, upon further consideration, please refer to the newly applied rejection(s), below.
New Claim Rejections - 35 USC § 103
17. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
18. Claims 38-40, 42, 120, 121, 127, 122-126 and 128 are rejected under 35 U.S.C. 103 as being unpatentable over Plachetka et al., U.S. 20030114476 A1 in view of Sutter et al. U.S. 20050203000 A1, in view of Cook et al., U.S. 20100284940 A1, and further in view of Levine et al., Biochemistry 1996.
This rejection is newly applied as a result of Applicant’s amendment to the claims.
Claim 38, as amended, is drawn to a pharmaceutically acceptable formulation comprising:
(a) about 3 mg/mL to about 6 mg/mL dihydroergotamine mesylate;
(b) dimethyl sulfoxide (DMSO);
(c) a pharmaceutically acceptable alcohol (more specifically, ethanol (claims 39 and 40));
(d) caffeine;
(e) an isomer of cresol (more specifically, m-cresol (claim 42));
(f) an inert gas at a concentration sufficient to retard oxidative degradation of the dihydroergotamine mesylate (more specifically, CO2 (claim 127); (g) an osmotic agent comprising dextrose; and
(h) an antioxidant comprising methionine,
wherein the pharmaceutically acceptable formulation is injectable.
Claim 120 is drawn to claim 38, and limits wherein the formulation has a pH between about 2.5 and about 4.5, (more specifically between about 3 and about 5 (claim 128)).
Claim 121 is drawn to claim 38, comprising about 4 mg/mL dihydroergotamine mesylate.
19. Plachetka teaches an injectable pharmaceutical formulation for the treatment of migraine headache, comprising (a) dihydroergotamine (DHE) mesylate and (d) caffeine:
“the DHE can be incorporated into formulations in any chemical form and administered to patients either as a free base or as a pharmaceutically acceptable salt. The most preferred formulation contains dihydroergotamine mesylate and caffeine at a 1:1 weight ratio,” (paragraphs [0010] and [0017]).
20. Plachetka goes on to teach that the pharmaceutical formulation comprises physiologically compatible organic solvents including (c) ethanol, (b) dimethyl sulfoxide, and (g) partial esters of glycerin and the like. Plachetka additionally teaches (f) an inert gas to retard oxidative degradation, specifically naming CO2 and incorporating (h) an antioxidant:
“[i]n order to prevent the oxidative degradation of DHE, preparations may be sparged with a non-oxidizing gas, e.g., nitrogen and/or CO2. If desired, pharmaceutically acceptable antioxidants may also be incorporated into drug preparations,” (paragraph [0018]).
21. Plachetka discloses a DHE formulation comprising dihydroergotamine mesylate; glycerin, and ethanol, wherein the pH is adjusted to 3.6 ± 0.2 (see Table 1 at page 2, right column). Plachetka teach that the formulation comprises DHE at a concentration of at least 2 mg/mL (paragraph [0011]). Thus, the “about 3 mg/mL to about 6 mg/mL dihydroergotamine mesylate” as required by claim 38, and the “about 4 mg/mL dihydroergotamine mesylate” as required by claim 121 are reasonably suggested by “at least 2 mg/mL” as taught by Plachetka because Plachetka’s use of the modifier “at least” indicates that a precise amount is not required for operability. In other words, it is evident in view of the record that no criticality is associated with the amount of dihydroergotamine required by the claim. Rather, in view of the teaching of Plachetka, one of skill in the art would have understood that any amount greater than 2 mg/mL such as “about 3 mg/mL” as in claim 38, would reasonably be expected to be effective. And, the optimization of result effect parameters (e.g., dosage range of carriers) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization with a reasonable expectation of success. And, the pH of 3.6 ± 0.2 meets the limitation of “pH between about 2.5 and about 4.5,” as required by claim 120, and “between about 3 and about 5,” as required by claim 128.
Therefore one skilled in the art would have chosen to formulate the DHE composition of Plachetka with “about 3 mg/mL to about 6 mg/mL” by weight of dihydroergotamine as required by claim 38.
22. Plachetka do not teach component (e) an isomer of cresol.
23. Yet, Plachetka teaches that mild pain at the injection site can occur following administration of the DHE formulation by injection (see paragraph [0046]).
24. Sutter et al. teach that “[i]In recent clinical trials it has been demonstrated that compounds or solutions containing preservatives in their formulation (bacteriostatic saline, insulin) have significantly lower pain scores for intradermal delivery than preservative-free solutions. The addition of benzyl alcohol (bacteriostatic saline), cresol (insulin) and aromatic preservatives to a formulation of an active compound reduces the subject's perception of pain during intradermal injection, presumably acting as a local anesthetic on the immediate tissue surface within the intradermal space, thereby making the perception of infiltration less noticeable.” (paragraph [0007]).
25. Sutter et al. go on to teach particularly preferred preservatives including cresol isomers, specifically m-cresol (paragraph [0012], line 9) and specifically name dihydroergotamine as a therapeutic substance to be used with said preservative (paragraph [0016], line 5).
Sutter et al. additionally teach that: “[t]he concentration of such agents in the formulation is generally anticipated to be less than about 10% (w/v), preferably less than 5%, more preferably less than or equal to 2%, most preferably less than or equal to 1% (typically 0.25% or less). Useful working ranges and optimal amounts can be determined by persons of skill in the art without undue experimentation,” (paragraph [0014]). The optimization of result effect parameters (e.g., concentration of carriers) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization with a reasonable expectation of success.
26. Plachetka in view of Sutter et al. teach a pharmaceutical formulation comprising the components (a) at least 2 mg/mL dihydroergotamine mesylate, (b) dimethyl sulfoxide, (c) ethanol, (d) caffeine, (e) an isomer of cresol, (f) CO2, (h) an antioxidant, and (g) the osmotic agent glycerin, but do not teach wherein the osmotic agent is dextrose.
27. Yet, Cook et al. teach pharmaceutical compositions comprising DHE for rapid relief of migraine that can be formulated for injection (paragraph [0075]) and may further comprise additional ingredients including preservatives, buffers, tonicity agents, antioxidants and stabilizers, nonionic wetting or clarifying agents, viscosity-increasing agents, absorption enhancing agents, etc (paragraph [0069]) including the tonicity agent dextrose (paragraph [0073]).
28. Plachetka in view of Sutter et al. and Cook et al. suggest a pharmaceutical formulation comprising the components (a) at least 2 mg/mL dihydroergotamine mesylate, (b) dimethyl sulfoxide, (c) ethanol, (d) caffeine, (e) an isomer of cresol, (f) CO2, (h) an antioxidant, and (g) the osmotic agent dextrose, but do not teach wherein the antioxidant is methionine.
29. Plachetka teach the inclusion of antioxidants (paragraph [0018]) and Cook et al. teach antioxidants (paragraph [0074]).
30. Yet, Levine et al. teach that methionine residues function as an endogenous antioxidant defense system (page 15040, left column, second paragraph), wherein “surface-exposed methionine residues of proteins provide an enormously high concentration of antioxidant at the protein surface, an ideal combination for defense against oxidation of key residues within the protein or even for protecting other molecules against oxidation.” Levine et al. suggest a concentration of methionine of around 100 mM (page 15039 right column, first paragraph). Methionine at a concentration of 100 millimolar (mM) is equivalent to 14.921 mg/mL (the molecular weight of methionine is 149.21 g/mol).
31. The optimization of result effect parameters (e.g., concentration of carrier/ antioxidant) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization with a reasonable expectation of success.
32. Thus, one skilled in the art would have been motivated to employ the components named in the injectable DHE formulation of Plachetka and the alternate/ additional components named in the DHE formulations of Sutter et al. and Cook et al., with the potent antioxidant methionine suggested by Levine et al., in order to formulate an improved DHE mesylate pharmaceutical formulation for injectable delivery with reduced pain on injection and protection against oxidation, with a reasonable expectation of success.
33. And, as stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976); Sundance, Inc. v. DeMonte Fabricated, Ltd., 550 F.3d 1356 (Fed. Cir. 2008): a claimed invention is obvious is it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they had been combined; Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945): indicating that “[r]eading a list and selecting a known component to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.
Thus, claims 38-40, 42, 120, 121, 127 and 128 are prima facie obvious.
Claim 122 is drawn to claim 38, comprising about 200 to about 750 mg/mL dimethyl sulfoxide. Claim 123 is drawn to claim 38, comprising about 200 to about 540 mg/mL dimethyl sulfoxide.
Claim 124 is drawn to claim 42 wherein the meta-cresol is at a concentration of about 1.5 mg/mL.
34. Plachetka teaches a DHE mesylate formulation comprising the component dimethyl sulfoxide in paragraph [0018]). Sutter et al. additionally teach that: “[t]he concentration of such agents in the formulation is generally anticipated to be less than about 10% (w/v), preferably less than 5%, more preferably less than or equal to 2%, most preferably less than or equal to 1% (typically 0.25% or less). Useful working ranges and optimal amounts can be determined by persons of skill in the art without undue experimentation,” (paragraph [0014]).
35. And, Cook et al. teach that preservatives (i.e., m-cresol) are employed at a level of from 0.001% to 1.0% by weight (paragraph [0071]). The optimization of result effect parameters (e.g., concentration of carriers) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization with a reasonable expectation of success.
36. Thus, one skilled in the art would have been motivated to employ the components named in the injectable DHE formulation of Plachetka and the alternate/ additional components named in the DHE formulations of Sutter et al. and Cook et al. and optimize the amounts of said components in order to formulate an improved DHE mesylate pharmaceutical formulation for injectable delivery, with a reasonable expectation of success.
As such, claims 122-124 are prima facie obvious.
Claim 126 is drawn to claim 38, wherein the methionine is at a concentration of about 1.5 mg/mL.
37. Levine et al. additionally suggest a concentration of methionine of around 100 mM (page 15039 right column, first paragraph). Methionine at a concentration of 100 millimolar (mM) is equivalent to 14.921 mg/mL (the molecular weight of methionine is 149.21 g/mol).
38. The optimization of result effect parameters (e.g., concentration of carrier/ antioxidant) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization with a reasonable expectation of success.
39. Thus, one skilled in the art would have been motivated to employ the components named in the injectable DHE formulation of Plachetka and the alternate/ additional components named in the DHE formulations of Sutter et al. and Cook et al., with the potent antioxidant methionine suggested by Levine et al., and optimize the amount of methionine in order to formulate an improved DHE mesylate pharmaceutical formulation for injectable delivery with protection against oxidation, with a reasonable expectation of success.
As such, claim 126 is prima facie obvious.
Response to Arguments
40. Applicant traverses the previous obviousness rejections, arguing that claim 38 is amended to require the limitation of “an antioxidant comprising methionine," to limit the osmotic agent to dextrose; and to limit to an injectable pharmaceutically acceptable formulation. Applicant argues the following points:
(i) Applicant alleges that Plachetka, Sutter, and Cook fail to teach the requirements of amended claim 38, because Plachetka, Sutter, and Cook each fail to disclose an antioxidant wherein the antioxidant comprises methionine, and fail to teach an osmotic agent wherein the osmotic agent is dextrose, wherein the pharmaceutically acceptable formulation is injectable. Applicant argues that Cook disclosure indicates that dextrose is used for an ophthalmic solution, not an injectable pharmaceutical formulation ("Suitable tonicity agents are . . ., dextrose, . . ., and the like, such that the sodium chloride equivalent of the ophthalmic solution is in the range 0.9 plus or minus 0.2%." Cook, [0073]). Applicant argues that one skilled in the art would understand Cook's disclosure of dextrose to be solely related to embodiments of formulations for ophthalmic use rather than formulations for injection, and would not have been motivated from Cook's disclosure to use an osmotic agent in an injectable pharmaceutical formulation of DHE, or to select dextrose as that osmotic agent.
41. Applicant's arguments have been fully considered but they are not persuasive. Cook et al. is directed to the rapid relief of migraine comprising administering DHE with a reduced side effect profile, wherein administration can be intravenous: “According to one aspect of the invention the Cmax of DHE administered by a method of the invention is at least 5-fold, 10-fold or 15-fold reduced from the Cmax of DHE administered by direct or slow bolus intravenous delivery. According to one aspect of the invention the Tmax of DHE administered by a method of the invention is at least 1 minute delayed from the Tmax of DHE administered by direct intravenous delivery, and the AUC (or area of the curve of the concentration of the drug in the systemic circulation versus time) of the drug delivered by the method of the invention is within 75% of the comparable IV delivered dose.” (see paragraphs [0019] and [0020]).
Cook et al. teaches that DHE formulation can be administered via many different routes, including several injectable: “According to the methods of the invention a DHE formulation may be administered by any mode, including but not limited to, intravenous, intra-arterial, intraperitoneal, intrapulmonary, oral, sublingual, buccal, intranasal, oral inhalation, intravesicular, intramuscular, intra-tracheal, subcutaneous, iontophoresis, transdermal, intraocular, intrathecal, transmucosal, and transdermal delivery,” (paragraph [0027]). Cook et al. go on to specifically teach tonicity modifiers for intravenous injection: “When preparing the composition for injection, particularly for intravenous delivery, the continuous phase preferably comprises an aqueous solution of tonicity modifiers,” (paragraph [0077]). In fact, the only mention of an ophthalmic composition at all is in paragraph [0074].
Therefore, the examiner respectfully disagrees with the assertion that the disclosure of dextrose to be solely related to embodiments of formulations for ophthalmic use. For the sake of argument, even if Cook et al. taught that ophthalmic preparations were preferred, "the use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005)(reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.").
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(ii) Applicant argues that Levine does not disclose methionine as an antioxidant suitable for an injectable formulation of DHE. Rather, Levine emphasizes the antioxidant properties of methionine residues in a protein contexts, making them structurally distinct from methionine as claimed. Accordingly, the methionine residues of Levine are not formulation components; they are residues within a protein that act to stabilize the protein-not a pharmaceutical agent such as DHE.
41. Applicant's arguments have been fully considered but they are not persuasive. In response to applicant's argument that the methionine taught by Levine is not drawn to an injectable pharmaceutical formulation, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the instant claims are drawn to a product (pharmaceutically acceptable formulation), not a method of use.
And, it is noted that the use of methionine in injectable formulations is known in the art, for example CN 10777353 B1 (see English translation) is directed to an ergot alkaloid formulation for administration via injection, comprising methionine as an antioxidant:
“the invention particularly provides a ergometrine maleate injection, which takes methionine as an antioxidant; wherein the mass ratio of the ergometrine maleate to the methionine is (0.1-1): (5-6). In the present invention, methionine is present in the form of an antioxidant, however, this should not be taken as a limitation of the scope of the present invention,” (page 2 under “disclosure of the invention”).
Therefore one skilled in the art would reasonably consider employing methionine as an antioxidant in the instantly recited formulation, with a reasonable expectation of success.
Conclusion
42. Claims 38-40, 42, 62, 118 and 120-133 are present in the application. Claims 62 and 129-133 are presently withdrawn from consideration. Claims 38-40, 42, 118 and 120-128 are rejected. No claim is currently allowed.
43. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
44. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JANET L COPPINS/Examiner, Art Unit 1628
/Rayna Rodriguez/Primary Examiner, Art Unit 1628
Prosecution Insights