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 .
Priority
This application is a National Stage entry of PCT/US2022/040490, International Filing Date: 08/16/2022.
PCT/US2022/040490 Claims Priority from Provisional Application 63316123, filed 03/03/2022.
PCT/US2022/040490 Claims Priority from Provisional Application 63234683, filed 08/18/2021.
Election/Restrictions
Applicant’s election of Etanercept as the therapeutic agent and rheumatoid arthritis as the disease/disorder in a subject in the reply filed on 6/25/2026 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)).
Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species (i.e. nonelected disease/disorder in the subject), there being no allowable generic or linking claim.
Claim Status
Receipt of Remarks filed on 6/25/2026 is acknowledged. Claims 3-20, 22, 24 are currently pending. Claims 9 has been withdrawn. Accordingly, claims 3-8, 10-20, 22, 24 are currently under examination.
Claim Objections
Claims 3, 4, 5 and 15 are objected to because of the following informalities:
Claims 3, 4 and 5 recite “first medical device”. The examiner suggests amending this limitation to delete “first” and just recite “medical device” because there is no “second” or “third” medical device recited in the claims. Thus, the recitation “first” appears to be unnecessary.
In claim 4, line 1-2 and second last line, the recitation “at least on lymph node” should recite “at least one lymph node”.
In claim 15, the recitation “DAS28(CRT)” should recite “DAS28(CRP)” as disclosed in paragraph 0192-0195 of instant specification. “CRT” appears to be a typo and should recite “CRP”.
Appropriate correction is required.
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 3-8, 10-20, 22, 24 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.
Claims 3, 4 and 5 recite “an end of at least one of the microneedles is proximate to the first position”. It is unclear which of end of the microneedles is referred to in this recitation. It is unclear whether it is referring to the bevel tip of the needle or whether it is referring to the end opposite of the bevel tip.
Claim 5 recites “wherein the therapeutically effective amount comprises an amount that results in restoration of the normal pumping rate to a rate that is comparable to or greater than the pumping rate in a subject that does not have the disease or associated condition”. The examiner interprets the normal pumping rate to be comparable to a pumping rate in a subject that does not have the disease or associated condition. However, the recitation above also recites greater than the pumping rate in a subject that does not have the disease or associated condition. Thus, it is unclear whether the therapeutic amount is effective to restore a normal pumping rate or whether it is an amount that is effective to result in greater than normal pumping rate.
Claim 8 recites the associated condition comprises another autoimmune condition. The use of “another” in this recitation suggests that this recitation is claiming there being an additional autoimmune condition. However, claim 8 depends from claim 4 which recites an arthritic disease or associated condition. There is no mention of the disease or associated condition being an autoimmune condition. Thus, there is insufficient antecedent basis for the limitation above in claim 8 which renders the claim indefinite because it is unclear which condition is an autoimmune condition in claim 4. Further, it is unclear if “another” is a typo and should instead recite “an” autoimmune condition. In view of the applicant’s election of rheumatoid arthritis (an autoimmune condition) as the disease/disorder, the examiner interprets the recitation in claim 8 as wherein the associated condition comprises an autoimmune condition.
Claim 13 contains the trademark/trade names Humira, Amjevita, Cimzia, Enbrel, Ereizi, Simponi, Simponi Aria, Remicade, and Inflectra. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade names are used to identify/describe Adalimumab (Humira), Adalimumab-atto (Amjevita), Certolizumab (Cimzia), etanercept (Enbrel), etanercept-szzs (Ereizi), Golimumab (Simponi, Simponi Aria), Infliximab (Remicade), and Infliximab-dyyb (Inflectra) and, accordingly, the identification/description is indefinite.
Claims 15-18 recite “at least 10%, at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, or greater”. It is unclear what exactly is the percent that is referred to when reciting “greater”. For example, “at least 10%” suggests that it is 10% or greater. The percentages in the limitations above are listed in the alternative and it is unclear what exactly is referred to when reciting “or greater” because all of the alternative percentages encompass greater than with the use of “at least” language.
Claims 6, 7, 10-12, 14, 19-20, 22, 24 are included in the rejection as they depend on a rejected base claim and do not clarify the issues discussed above.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 3-4, 6-8, 10-14, 19-20, 22 and 24 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Ross (WO2019232265A1)(Cited previously in Restriction Requirement).
Ross teaches the disclosure relates to the administration of a medicament to a patient suffering from medical condition that can be ameliorated by the administration of a medicament to the lymphatic system of the patient. Ross teaches methods of treating an inflammatory medical condition in a patient, for lowering the TNF-alpha (inflammatory substance) level in a patient, and administering therapeutic agent to the lymphatic system of a patient. Ross teaches wherein the inflammatory condition is rheumatoid arthritis (an autoimmune condition) and the therapeutic agent is etanercept which inhibits TNF alpha (also reads on anti-inflammatory agent and anti-arthritic agent). Ross discloses that tumor necrosis factor alpha (TNF-alpha) has become a significant therapeutic target in connection with a large variety of medical conditions, including rheumatoid arthritis (RA).
Ross teaches placing a first medical device comprising a plurality of microneedles on the skin of the patient at a first location proximate to a first position under the skin of the patient, wherein the first position is proximate to lymph vessels and/or lymph capillaries that drain into the right lymphatic duct, and wherein the microneedles of the first medical device have a surface comprising nanotopography; inserting the plurality of microneedles of the first medical device into the patient to a depth whereby at least the epidermis is penetrated and an end of at least one of the microneedles is proximate to the first position; and administering via the microneedles of the first medical device a dose of the therapeutic agent into the first position.
Ross teaches administering a therapeutically effective amount of an immune-suppressing agent (e.g. etanercept) that is effective in lowering the TNF-a level in the patient. Ross specifically teaches administering via the plurality of microneedles to the selected lymph capillaries and/or lymph vessels of the patient a therapeutically effective amount of drug that inhibits TNF-alpha.
Ross further teaches the method of increasing lymphatic pumping rate. Specifically, Ross teaches, as shown in Figures 5B-5G, administration of etanercept decreased joint swelling overtime and the lymphatic pumping rate correlated with the decrease in joint swelling. As shown in Figures 6 and 7A to 7D, administration of etanercept significantly increased the lymphatic pumping rate as compared to untreated groups, which reads on effective amount that increases lymphatic pumping rate.
Ross teaches an “effective amount” or a “therapeutically effective dose” in reference to a medicament is an amount sufficient to treat, ameliorate, or reduce the intensity of at least one symptom associated with the medical condition, which reads on claim 6.
Regarding dose sparing amount of the therapeutic agent recited in claim 14, Ross teaches the need to develop a dosing regimen or method that maintains a therapeutically effective dose of the therapeutic agent in a patient while reducing the overall patient exposure to the therapeutic agent. Ross also teaches the overall dose of the therapeutic agent at each location must be carefully adjusted such that the patient does not receive an overall unsafe combined dose of the agent. Being able to more selectively target specific locations in or on the body of a patient more precisely often means a lower dose is required at each specific location. In some embodiments, the dose administered to target one or more locations on the body of a patient is lower than a dose administered by other routes, including intravenous and subcutaneous administration. Thus, Ross teaches using dose sparing amount of therapeutic agent (i.e. using lower dose while maintaining efficacy). Ross also teaches wherein the patient is a mammal and wherein the patient is a human.
Regarding claims 22 and 24, Ross teaches wherein the medical device comprises a fluid delivery apparatus, wherein the fluid delivery apparatus comprises: a fluid distribution assembly wherein a cap assembly is coupled to a cartridge assembly, and the cartridge assembly is slidably coupled to a plenum assembly, and a mechanical controller assembly is slidably coupled to the cartridge assembly; a collet assembly constituting the housing of the fluid delivery apparatus and being slidably coupled to the fluid distribution assembly; and a plurality of microneedles fluidically connected with the fluid distribution assembly having a surface comprising nanotopography, the plurality of microneedles being capable of penetrating the stratum corneum of the skin of a patient and controllably delivering the therapeutic agent to a depth below the surface of the skin. Ross teaches wherein each of the microneedles in the medical device has a length between about 200 to about 800 micrometer, between about 250 to about 750 micrometer, or between about 300 to about 600 micrometer. (see e.g. Abstract; Claims; para 0002; 0007; 0135; 0153; 0193-0214; 0262-0266; Figures 5, 6 and 7; entire document).
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.
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.
Claims 5 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ross (WO2019232265A1)(previously cited) as applied to claims 3-4, 6-8, 10-14, 19-20, 22 and 24 above.
The teachings of Ross discussed supra are incorporated herein.
Ross does not expressly teach the therapeutically effective amount comprises an amount that results in restoration of normal pumping rate that is comparable to or greater than the pumping rate in a subject that does not have the disease. However, as discussed supra, Ross teaches the method of increasing lymphatic pumping rate. Specifically, Ross teaches, as shown in Figures 5B-5G, administration of etanercept decreased joint swelling overtime and the lymphatic pumping rate correlated with the decrease in joint swelling. As shown in Figures 6 and 7A to 7D, administration of etanercept significantly increased the lymphatic pumping rate as compared to untreated groups.
It would have been prima facie obvious to one or ordinary skill in the art to have determine the therapeutically effective amount that results in restoration of normal pumping rate through routine optimization. Ross teaches the disclosed method of administering etanercept significantly increased the lymphatic pumping rate and based on this, one skilled in the art would have found it obvious to manipulate the amount of etanercept during routine optimization and determine an amount that would provide a normal pumping rate which is comparable to the pumping rate in a patient that does not have the disease. Moreover, it would have been obvious to know that a normal pumping rate, such as in a subject without the disease, would be desired. “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05.
Regarding claim 15-18, Ross does not expressly teach the therapeutically effective amounts that reduce a DAS28(ESR) and/or a DAS28(CRP) score, 66/68 joint count and/or a 28 joint count score, patient rating of the overall disease, and improve ACR response, however, these are all scores and/or ratings which determine effectiveness of the treatment in rheumatoid arthritis. As discussed supra, Ross teaches an “effective amount” or a “therapeutically effective dose” in reference to a medicament is an amount sufficient to treat, ameliorate, or reduce the intensity of at least one symptom associated with the medical condition. Thus, it would have been prima facie obvious to one or ordinary skill in the art to have determine, through routine optimization, the therapeutically effective amount that results in maximum reduction of DAS28(ESR) and/or a DAS28(CRP) score, 66/68 joint count and/or a 28 joint count score, patient rating of the overall disease, and maximum improvement in ACR response. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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 experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
Conclusion
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/ALI S SAEED/Examiner, Art Unit 1616
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