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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 13, 2026 has been entered.
Terminal Disclaimer
The terminal disclaimer filed on April 13, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on US Application No. 18/270682 has been reviewed and is accepted.
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 21-27 and 36 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.
Claim 21 recites “wherein the subcutaneous biodegradable medical implant comprises a plurality of implant units configured to release a dosage amount of naltrexone into the blood stream of the patient inserted into the patient at a 45⁰ (degree) angle”. It is unclear if the “inserted into the patient at a 45⁰ (degree) angle” recitation is part of the functionality recitation of the implant that starts with the text “configured to release a dosage amount” or if the recitation is a required step of the method of treating. The placement of the statement at the end of a recitation discussing release kinetics of the implant as opposed being a part of the earlier recitation that recites “subcutaneously administering…a subcutaneous…implant” or as its own active step appears to lean toward the former interpretation as more aligned with the claim construction. It is not clear why or how the insertion angle influences the ability of an implant to release naltrexone. Thus for the sake of compact prosecution and the application of prior art employing the broadest reasonable interpretation, the limitations of the insertion angle will be deemed as met by a plurality of implants that release naloxone. Clarification is still required.
Claim 27 recites a reduced BMI after about 12 weeks from the placement time; however, the parent claim recites that the sustained release of naltrexone occurs for up to 8 weeks. It is unclear if additional unrecited actions, such as program administration, are implicitly required in the time between when the drug administration stops and this recited time point. Thus the scope of required active steps is not clear.
Claims that are rejected, but are not explicitly elaborated upon, are also indefinite because they depend from a rejected claim and do not add clarity.
Claim Rejections - 35 USC § 103
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 21-27 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over McKinney et al. (US PGPub No. 2007/0129283 – previously cited) in view of Goonoo et al. (previously cited), Farra et al. (previously cited), McKinney B (US Patent No. 8,916,195 - previously cited), Sidman (previously cited), Saxena et al. (previously cited), O’Neill et al. (previously cited), McElroy et al. (previously cited), and Wai et al. (previously cited) as evidenced by Hyde et al. (previously cited).
McKinney et al. teach the reduction of food cravings to invoke weight loss by the administration of opioid antagonist, namely naltrexone, that is further improved by the administration of an a-melanocyte stimulating hormone (see abstract and paragraphs 23, 68, and 71, and 188; instant claim 36). Specifically, a patient population with a body mass index (BMI) greater than 25 is of interest in the method where the administration of the combination of actives achieves weight loss (see paragraph 70 and examples). The BMI is taught to indicate whether a subject has a normal weight, is overweight, or is obese (see paragraph 70). Naltrexone in combination with bupropion is an exemplified oral combination that produces weight loss at 10% of initial weight every six months and can be adjusted as desired (see example 6; instant claims 25-27). Determination of this degree of loss implicitly requires measuring the weight and determining the BMI of the patient after administration (see instant claims 21 and 31). The administration of the drugs is not explicitly taught to occur via an implant.
Goonoo et al. teach of several injected and implantable naltrexone formulations (sea abstract). In particular, they teach of the disadvantages of oral delivery in its quick metabolism by the liver and reliance on patients to be compliant with the required dosing regimen (see page 156 second column last partial paragraph-page 157 second column first partial paragraph). Subcutaneous implants are taught as an alternative delivery route that avoids these issues of oral administration (see page 158 second column second full paragraph).
Farra et al. teach subcutaneous placement of a sustained release implant as a replacement for daily administration of hormonal active to address poor patient compliance (see abstract, page 2 first column first-second paragraphs). Specifically, this placement occurs in the lower abdomen below the waistline, in a subcutaneous pocket above the muscle fascia (see page 8 second column third full paragraph; instant claim 21).
McKinney B teaches the co-administration of sustained release naltrexone with bupropion for weight loss (see column 4 lines 15-19 and claim 1). Mean plasma concentrations of naltrexone that are generated by their sustained release naltrexone composition range from 1.17-2.55 ng/ml (see table 14).
Sidman teaches biodegradable implants that may be implanted subdermally and release naltrexone over time (see column 4 lines 42-54, column 11 lines 35-43, and examples 3-4; instant claim 21). Hyde et al. demonstrate that ‘subcutaneous’ and ‘subdermal’ are descriptive terms that may be employed interchangeably to describe the intended placement of an implant under the skin (see paragraphs 1-2, 10, and 32). The implants are made only of naltrexone and polymer; thus they are devoid of steroid (see examples 3-4). Sidman goes on to teach that the desired dosing of naltrexone can be achieved by employing drug loading levels up to 90 wt%, sizing a single implant sufficiently large, or providing several smaller sized implants that collectively achieve the same dosing level (see column 12 lines 43-49 and example 6; instant claims 21-22). The polymer of the implants degrades into amino acids and amino acid complexes and the implants are envisioned as rod shaped (see column 4 lines 43-54 and column 5 lines 36-39). Sidman teaches that the rate of drug release may be constant when configured with drug containing layers of increasing concentration from the surface to the core or it may be decreasing when designed to have an increasing surface area due to degradation over time (see column 11 lines 10-43; instant claim 23). The release duration can be predetermined as desired, where one month durations or longer are possible (see column 21 lines 16-22; instant claims 21 and 24). Sidman measures release from an implant over 28 days which implies that full degradation of the device occurs at some time after about 30 days (see example 3 and table 3; instant claim 24).
Saxena et al. teach biodegradable subcutaneous implants that provide a declining rate of release of naltrexone over time as it degrades and may be provided as 1 to 5 tablets (see paragraphs 21, 26, and 117 and figure 2; instant claim 23). They further teach the implants to produce a blood concentration of greater than 1 ng/ml over multiple months and saw that their level of naltrexone release results in moderate weight loss (see paragraphs 25 and 119-120; instant claim 21). Saxena et al. more specifically teach a blood concentration range of 1 ng/ml to 5.2 ng/ml per day can be achieved over three months or more (see claim 10). Naltrexone is provided from the implant set with a naltrexone amount of 0.5 to 2 g (see paragraph 41; instant claim 21). Saxena et al. teach the lower abdomen as the region for subcutaneous implantation (see paragraph 31; instant claim 21).
O’Neil et al. teach biodegradable subcutaneous implants that provide a declining rate of release of its active over time as it degrades (see paragraphs 12 and 57, example 6, claims 1, 3, 14, 38, 44, and 53-56; instant claim 23). Embodiments of the invention with naltrexone are detailed as multi-pellet implants and tested in rats and humans showing gradually diminishing amounts of naltrexone release over an extended timespan (see examples 1, and 3-6, figures 13, 16, and 19). The human test showed daily blood concentrations of naltrexone ranging from 1 to 15 ng/ml which is similar to that shown instantly as achieving weight loss (see instant specification tables 1-4 and 6-7; instant claim 21). More broadly, O’Neil et al. teach the benefit of the multi-unit implant permitting more comfort for patients than single unit implants (see paragraph 71; instant claim 22). Delivery durations are envisioned to span from more than 40 days to at least 3 years, where naltrexone is provided from the implant set at an amount of about 1 to about 20 g (see paragraphs 31 and 34). Narrower ranges are envisioned that include about 3 to about 15 g and about 3.6 to about 7.2 g, while they detail that particular choices are made by the artisan of ordinary skill (see paragraph 31; instant claim 21). More detailed discussion is also provided by O’Neil et al. of discrete amounts of naltrexone delivered by the implant set based upon the duration of release desired and the daily concentration that include 1 g and 2 g (see paragraph 95; instant claims 37-39). In addition, an implant with at least two pellets is envisioned, where 3.6 g of naltrexone is collectively provided by the implant set (see claim 56; instant claim 41). O’Neill et al. also teach the abdomen as the locale for subcutaneous implantation (see paragraph 57). They detail the process of insertion to be conducted from injection through a needle (see paragraphs 58-67).
McElroy et al. detail the administration of a sustained release naltrexone and sustained release bupropion to overweight or obese patients in combination with dietary (nutritional) and behavioral counseling from a registered dietician to elicit weight loss (see abstract and page e2 second column third full paragraph). The combination was found to be helpful and resulted in a weight loss of 10%, relative to the start weight over 24 weeks (see figure 1B).
Wai et al. teach clinical weight loss programs to be administered by licensed health providers that include physicians and dieticians (see page 197 first column first partial paragraph). Such programs can include nutritional counseling as well as prescriptive therapy and surgery (see page 197 first column first partial paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat patients with naltrexone in order to reduce their BMI via weight loss, as suggested by McKinney et al. More specifically, it would have been obvious to reach this end by subcutaneously administering a set of implants as taught by Sidman that release drug for one month or a longer duration, where both naltrexone and bupropion are present in each implant to recapitulate the impact of their oral administration as taught by McKinney B. This drug combination is not taught to include a steroid. The conversion of an oral administration to a subcutaneous implant administration would have been obvious based upon the guidance by Goonoo et al. of the benefit of such a transition as the application of the same technique to a similar product/process in order to yield the same improvement. Further, Saxena et al. already note the recognized ability of the subcutaneous implant delivered naltrexone to yield weight loss and O’Neill et al. elaborate on subcutaneous implant delivered naltrexone configurations in regard to dosing levels, release kinetics as well as the ensuing blood plasma concentrations. In conjunction with the drug based treatment of excess weight, it would have been obvious to add dietary counseling as discussed by McElroy et al. to the modified method of McKinney et al. to further support their goal of weight loss because the combination of drugs and the desired outcome in the modified McKinney et al. teachings are the same as that in McElroy et al. Further, utilizing a licensed dietician as taught by Wai et al. to provide the nutritional therapy for the modified method of McKinney et al. would also have been obvious because the therapy involves both medicinal treatment and counseling and Wai et al. detail licensure as the desirable credentialing for the providers of such therapy.
The modification requires choices be made for the 1) implant formulation such that a useful release duration is attained, 2) dosing amount of the drugs and associated number of inserted implants, and 3) the location of insertion and the manner in which the insertion occurs:
The range of the release durations (and corresponding degradation rates) of Sidman overlaps with that instantly claimed and the desired duration over which naltrexone is provided is detailed as adjustable as desired by McKinney et al., thereby rendering the instantly claimed release duration obvious (see instant claim 21). “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). The blood concentrations of naltrexone that are known to be useful for producing weight loss taught by McKinney B were known to be generated by the implant provided dosing levels of Sidman, Saxena et al., and O’Neill et al. Further, the duration of release of O’Neill et al. also falls within the range of McKinney et al. and also overlaps the instantly claimed range, thereby rendering the instantly claimed release duration obvious.
It would also have been obvious to utilize multiple tablet/rod implants for implantation and the loading amounts of naltrexone as taught by O’Neill et al. in the implants. This modification would have been obvious because a) the duration of release of O’Neill et al. falls within the range of McKinney et al., b) the dosing of O’Neill et al. provides a level of daily naltrexone in the blood known to yield weight loss, and c) the benefit of increased patient comfort was recognized (application of the same technique to a similar process in order to yield the same improvement). The discrete values disclosed by O’Neill et al. are nearly the same as those instantly claimed, fall within the narrow range taught by O’Neill et al., and the instant specification does not demonstrate the criticality of the naltrexone amount, thus the claimed values are obvious over these teachings (see MPEP 2144.05). Further, the blood concentrations attained by the dosing concentration level of Saxena that also yield weight loss overlap at the lower of these ranges of parameters that are also taught by O’Neill et al. Thus there would have been a reasonable expectation of success for the dosing and release kinetics to achieve weight loss.
Additionally, it would have been obvious to implant the devices subcutaneously in the lower abdominal region above the muscle fascia as taught by Farra et al. and generically taught by O’Neill et al. This choice would have been obvious because they teach this location as suitable for drug delivery and the latter also teaches achieving similar blood concentration levels of naltrexone as the sustained release orally administered naltrexone of McKinney B. Thus the implantation of the implants with this location and their envisioned range of naltrexone amounts as multiple pellets would have been obvious. "A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim." Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1172 (Fed. Cir. 1993). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.") (see MPEP 2111.04). The wherein clauses of instant claims 25-27 and 36 merely characterize the results of those steps. Therefore, it is determined that the "wherein" clauses are not entitled to weight in construing the claims. Moreover, adjustment to the rate of weight loss would follow from the prior art teachings in accordance with the suggestion by McKinney et al. to adjust this rate as desired (see instant claims 25-30).
Therefore claims 21-27 and 36 are obvious over McKinney et al. in view of Goonoo et al., Farra et al., McKinney B, Sidman, Saxena et al., O’Neill et al., McElroy et al., and Wai et al. as evidenced by Hyde et al.
Claims 21-27 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over McKinney et al. in view of Goonoo et al., Farra et al., McKinney B, Sidman, Saxena et al., O’Neill et al., McElroy et al., and Wai et al. as evidenced by Hyde et al. as applied to claims 21-27 and 36 above, and further in view of Doyle et al. (Clinical Procedures for Safer Patient Care Chapter 7, Section 7.2 “Parenteral Medications and Preparing Medications from Ampules and Vials” 2015 opentextbc.ca/clinicalskills/chapter/safe-injection-administration-and-preparing-medication-from-ampules-and-vials) and Amirouche et al. (previously cited).
McKinney et al. in view of Goonoo et al., Farra et al., McKinney B, Sidman, Saxena et al., O’Neill et al., McElroy et al., and Wai et al. as evidenced by Hyde et al. render obvious the limitations of instant claims 21-27 and 36. O’Neill et al. detail the process of insertion of subcutaneous naltrexone releasing pellets/tablets via injection through a needle (see paragraphs 58-67). The angle of insertion into the subcutaneous region is not detailed.
Doyle et al. teach the proper angle for injection of medication into various parenteral spaces (see pages 1-2 and figure 7.1). They illustrate subcutaneous injection being performed at a 45⁰ angle (see figure 7.1).
Amirouche et al. teach an indwelling device with a portion that is implanted into subcutaneous tissue at a 45⁰ angle (see paragraph 100).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ an insertion angle that was known to be effective/proper for the subcutaneous placement of medication and for the implantation of an indwelling device in the modified method of McKinney et al. Thus a 45⁰ angle as taught by Amirouche et al. and Doyle et al. would have been obvious to utilize. Therefore claims 21-27 and 36 are obvious over McKinney et al. in view of Goonoo et al., Farra et al., McKinney B, Sidman, Saxena et al., O’Neill et al., McElroy et al., and Wai et al., Doyle et al., and Amirouche et al.as evidenced by Hyde et al.
Response to Arguments
Applicant's arguments filed April 13, 2026 have been fully considered. In light of the amendment to the claims, new grounds of rejection are detailed to address the new combination of claim limitations. The applicant’s arguments concerning the applicability of Amirouche et al. are unpersuasive.
The applicant argues that Amirouche et al. is inapplicable to the instant claims because they insert a fluid delivering cannula while the instant invention inserts a biodegradable implant. In both instances, an implantable device is implanted subcutaneously. While the cannula of Amirouche et al. is not the same as the implant structures taught by Sidman et al, Saxena et al., and O’Neill et al. or that instantly recited, the prior art devices are all cylindrical indwelling devices intended to be placed in the subcutaneous region for an extended period of time. Thus the discussion of Amirouche et al. is applicable to the instant claims and cited prior art. Further, Doyle et al. also details that the insertion angle for injection placement is important and was known to be a 45⁰ angle for subcutaneous injection. In spite of the claim not clearly inserting the claimed implant at a 45⁰ angle, such an insertion would have been obvious.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
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