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 .
Status of the Application
The Application remains in the Track One program.
The amendment and remarks of 29 August 2025 are entered.
Claims 1-18 and 30 have been canceled. Claims 19-29 and 31-46 are pending and are being examined on the merits.
The restriction requirement remains in effect.
The objection to claims 40 and 41 is withdrawn in light of the amendment filed 29 August 2025.
The rejection of claims 19-29 and 31-46 under 35 U.S.C. 103 as being unpatentable over ‘793, ‘126, ‘606, and ‘431 is maintained, with the Examiner’s response found below.
The rejection of claims 19-29, and 31-43 for nonstatutory double patenting over the ‘700 application is withdrawn in light of the amendment filed 23 September 2025 in the ‘700 application distinguishing from the instant claims.
The rejection of claim 37 for nonstatutory double patenting over ‘700 in view of ‘126 is withdrawn in light of the amendment filed 23 September 2025 in the ‘700 application distinguishing from the instant claims.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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. 119(b) 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).
The disclosure of the prior-filed applications, Application No. EP 20171240.3, 21151004.5, and EP 20157963.8, 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. None of the references discloses cagrilintide, alone or in combination with semaglutide. The earliest foreign priority date that can be assigned to the Application is 17 June 2020.
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 19-29 and 31-46 are rejected under 35 U.S.C. 103 as being unpatentable over Bendix et al. (WO 2010/139793 A1, published 9 December 2010, hereafter referred to as ‘793), Engelund et al. (WO 2020/084126 A1, published 30 April 2020, hereafter referred to as ‘126), L’Italien, J. and Stetsko, G. (US 2003/0092606 A1, published 15 May 2003, hereafter referred to as ‘606), and Shäffer et al. (WO 2012/168431 A2, published 13 December 2012, hereafter referred to as ‘431).
The ‘793 application discloses medical devices with first and second chambers (see e.g. claim 1).
The difference between ‘793 is that ‘793 does not disclose the claimed contents of the first and second chambers.
The ‘126 art discloses semaglutide formulations with isotonic agents, histidine, and a pH of 6-10 (see e.g. claim 1). The composition can contain a phosphate buffer (see e.g. claims 7-8). The composition can also be placed in a prefilled syringe or cartridge and may be used to treat diabetes (see e.g. claims 10 and 13-15). An example of the phosphate concentration is one at 1.42 mg/ml, along with 10 mM histidine, 18.5 mg/ml propylene glycol, and 0.5 mg/ml semaglutide at pH 7.4 (see e.g. Example 1). Other guidance suggests the buffer can be at 0.01-50 mM (see e.g. Embodiment 29).
The ‘606 art discloses amylin agonists in a liquid formulation along with an excipient, a carbohydrate, glutamate or acetate buffer at 0.02-0.5% w/v, and a pH of 3.8-4.2 (see e.g. claims 1, 2, and 5). Pramlintide can serve as the specific agonist (see e.g. claim 11). The mixture may be used along with an insulin pump (see e.g. claim 16). The composition is useful for treatment of diabetic patients (see e.g. claim 26).
The ‘431 application discloses cagrilintide (see e.g. claim 10). The composition can be used as a medicament for treatment of diabetes (see e.g. claims 11 and 12). The composition can also be prepared as a pharmaceutical composition with an excipient (see e.g. claim 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the drug delivery device of ‘793 and place a semaglutide formulation as in ‘126 into a first chamber and an amylin agonist formulation as in ‘606 in the second chamber. The rationale for separation in the device comes from the distinct pH values of the two compositions such that one of ordinary skill would seek to separate the semaglutide and amylin formulations to prevent degradation due to pH changes from the baseline formulations. Inclusion of both in the device would arise from their common treatment of diabetes, such that the skilled artisan would seek to combine them into a single drug delivery application. Furthermore, the skilled artisan would utilize a specific amylin agonist as disclosed in ‘431 in the form of cagrilintide since it is specifically claimed by ‘431 as a useful amylin agonist and superior to pramlintide. In this case, one of ordinary skill in the art would merely be substituting a known species for another known species. There would have been a reasonable expectation of success because the semaglutide formulation was known, the amylin agonist was also known for treatment of diabetes, and one of ordinary skill would expect joint usage to be enhanced by separation due to differing pH values of the formulations. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claim 20, the semaglutide is disclosed as 0.1-10 mg/ml, and the amylin agonist at 0.5-1% (w/v), covering both ranges.
With respect to claims 21 and 31, the device offers two chambers, and as a result they are proximal or distal as needed depending on orientation of the device.
With respect to claims 22 and 32, as set forth above both pH values are covered by the base formulations.
With respect to claims 23 and 33, the glutamate buffer range covers 2-10 mM.
With respect to claim 24, the ‘431 art also discloses lactic acid as an acceptable buffer for the cagrilintide (see e.g. p.93 line 33 to p.94 line 2). Utilizing it in place of the buffers of ‘606 through simple substitution of one known buffer system for another known buffer system would cover the range as claimed.
With respect to claims 25 and 35, the phosphate buffer range encompasses 30 mM.
With respect to claims 26 and 36, the semaglutide formulation includes histidine.
With respect to claims 27 and 38, an isotonic agent is included with the semaglutide, i.e. a tonicity agent.
With respect to claims 28 and 39, ‘126 allows for propylene glycol as the isotonic agent (see e.g. claim 9).
With respect to claims 29 and 40-43, the ‘606 application allows for inclusion of mannitol (see e.g. claims 12-13). Preparation of the overall conditions is merely a matter of routine experimentation within the ranges of ‘606, ‘126, and ‘431.
With respect to claim 37, the ‘126 application suggests 10 mM histidine as set forth above.
With respect to claim 44, the ‘606 application allows for glycerol at 1-10% w/v. The ‘126 art discloses isotonic agents at 8-50 mg/ml (see e.g. Embodiment 32). Sodium chloride is a known isotonic agent and also included commonly with semaglutide formulations (see e.g. FDA approval for WEGOVY, containing 8.25 mg/ml NaCl). Preparation of the claimed mixtures is merely a routine of routine experimentation within known and disclosed conditions in the prior art.
With respect to claim 45, as set forth above inclusion of 10 mM histidine is suggested by ‘126.
With respect to claim 46, the NaCl range falls within the isotonic agent range of ‘126.
Response to Arguments:
The Applicants argue none of the references alone or in combination provide a suggestion to combine semaglutide formulation and cagrilintide formulation into a dual chamber device.
The Examiner disagrees. A dual chamber device was known per ‘793. Semaglutide and cagrilintide formulations were known per ‘126 and ‘431. Amylin agonists, including pramlintide, were known for treatment of diabetic patients per ‘606, and ‘431 establishes that cagrilintide is more effective than pramlintide. The Examiner argues it reasonably follows that the amylin agonist formulation would have been placed in a chamber separate from semaglutide due to pH differences, and, since cagrilintide was recognized as a better amylin agonist than pramlintide, the person of ordinary skill in the art would have been motivated to utilize cagrilintide with semaglutide.
The Applicants argue ‘793 only describes a two chambered device but does not describe the contents. The Applicants admit ‘126 describes semaglutide formulations, ‘606 describes pramlintide formulations, and ‘431 describes cagrilintide.
The Examiner agrees on the content of the prior art references as disclosed in the rejection of record.
The Applicants argue the Examiner states it would have been obvious to place semaglutide in a first chamber and an amylin agonist in a second chamber because both could have treated diabetes.
The Examiner agrees on the initial basis for obviousness.
The Applicants argue many compounds are available for diabetes treatment and that none of the cited references disclose putting semaglutide and cagrilintide into one device.
The Examiner agrees that no single reference discloses the invention as claimed, which is why the rejection is based upon the combination of the cited above references. The Examiner emphasizes that this is not an anticipation rejection under § 102. Therefore, there is no requirement that a single reference discloses or fairly suggests the claimed invention.
The Applicants argue a reasonable expectation of success is required to demonstrate obviousness. The Applicants argue no expectation that combining the semaglutide and cagrilintide into a dual chamber device would have been successful.
The Examiner agrees a reasonable expectation of success is required. The Examiner argues a reasonable expectation has been established. The individual elements were known. A dual chamber device was known. The claims require nothing other than placing these in a device. The skilled artisan could reasonably achieve this with the prior art references as cited.
The Applicants argue that cagrilintide was stable at pH 3.5-4.5 and semaglutide was stable at pH 7-8. The Applicants argue co-formulation cannot be achieved due to this pH difference.
The Examiner agrees on pH stability. The Examiner argues that the concerns regarding pH stability and different formulation pH requirements has been addressed in the rejection of record as a reason to keep the formulations in separate chambers.
The Applicants argue that during injection the formulations come into contact as they are ejected through the same outlet/needle in the device. The Applicants point to the specification for a description of how the dual chamber device works during injection.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., injection or mixing of the formulations) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). All that is required of the claims are semaglutide and cagrilintide formulations that are kept in separate chambers of a medical device. That is offered through combination of the prior art references.
The Applicants argue upon co-ejection of cagrilintide and semaglutide due to pH differences one of ordinary skill in the art would expect a decrease in stability through formation of visible or sub-visible particles. The Applicants argue thus it would not be successful to combine the formulations into a single dual delivery device.
Again, the Applicants are arguing features that are not claimed. Nothing in the claims requires mixing or delivery of the formulations; the only requirement is that they be placed in separate chambers. Similarly, there is nothing in the claims requiring stability of a mixed formulation. As to stability after mixing, this is firstly not a claim limitation, and secondly there is no evidence provided to establish that this would be an issue since presumably the mixed formulation is injected and cleared after mixing.
The Applicants argue failed attempts at storage of semaglutide and cagrilintide formulations in dual chamber devices since particles formed during injection through the device. Applicants cite to statements made on pages 4-5 of their specification filed on January 17, 2025.
Again, the absence of the formation of particles, when semaglutide and cagrilintide pharmaceutical formulations are present in separate chambers of a dual chamber medical device are not recited limitations of the claimed medical device.
The Applicants argue a lack of obviousness because there is no teaching or suggestion to combined the formulations in a dual chamber devices.
The Examiner disagrees for the reasons above and in the rejection of record.
The Applicants argue unexpected results. The Applicants point to Examples 3 and 4 as demonstrating cagrilintide mixing with semaglutide without instability and lack of particle formation because cagrilintide contributes to buffer capacity.
The claims are not commensurate in scope with any alleged unexpected results. Nothing in the claims requires anything regarding levels of particle formation. The only requirement is a dual chamber device containing a semaglutide formulation in one chamber and a cagrilintide formulation in the other, which is offered by the above prior art. Similarly, contribution of buffer capacity by cagrilintide is not commensurate in scope with any claim limitations.
The Applicants point to the claimed semaglutide formulation containing more than 15 mM and less than 45 mM phosphate. The Applicants argue ‘126 does not suggest such a formulation might be more chemically or physically stable when mixed with cagrilintide. The Applicants argue increasing phosphate above 15 mM surprisingly reduces formation of precipitate and obtaining of better stability.
The Examiner firstly notes that ‘126 guides towards phosphate concentration including a 15-45 mM range as found in Embodiment 29 as cited in the rejection of record. Secondly, the arguments concerning chemical or physical stability as a result of phosphate concentration are not commensurate in scope with the claims, as nothing in the claims requires anything regarding precipitate formation or physical stability. Again, the Applicants are arguing features that are not claim limitations.
The Applicants point to Example 6 for improved clinical effect when administration is achieved through the dual chamber device as compared to separate injection devices and that this is unexpected.
Again, the Applicants are arguing features that are not claimed. Nothing in the claims requires administration of the formulation or a particular clinical effect; the formulations only need to be placed in a dual chamber device. Moreover, Applicant’s rejected claims are not drawn to a method of use. Consequently, the recitation of an intended use of the claimed medical device, a product, would be given little patentable weight.
The Applicants’ arguments have been considered but are not persuasive. The rejection is maintained.
Conclusion
No claims are 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 ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached M-F 9-5.
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/Z.J.M/Patent Examiner, Art Unit 1658
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622