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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 28-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims recite a range of BMI reductions that occur after a minimum amount of time has elapsed after placement of the claimed naltrexone containing subcutaneous implant. The implant must provide 1.1 g to 4 g of naltrexone over no more than eight weeks of elution time. The instant specification details achieving weight reductions from a study that subcutaneously implants a degradable implant with 800 mg of naltrexone (see paragraph 62-63). The specification does not disclose the duration over which naltrexone is delivered from the implant in this study or detail that a program of counseling or therapy was delivered by a licensed professional. Weight loss for two patients at 4 weeks is measured and corresponds to a 2% reduction in BMI (see tables 4-6). One additional patient is assessed at 4 weeks and showed no weight loss and no measured values are shown for the remaining three patients at the 4 week time point (see table 4). Via undisclosed calculations, the specification projects BMI values for one month, two month, and three month time points for all six subjects in tables 6 and 7. No basis is provided for these projections, so their validity is unknown, given that it projects a non-zero 1 month weight loss for a patient that had no weight loss after four weeks (see participant 2598 in tales 5-7). The 2% reduction in BMI is within the range of claim 28, but resulted from an implant with 800 mg naltrexone and the release duration was not detailed (see paragraphs 62-63 and 69 and table 5-6). There is no discussion of how an implant is configured (e.g., necessary release duration), such that the claimed 1.1 g to 4 g loading of naltrexone in an implant, coupled with the claimed program of therapy or behavioral or nutritional counseling, performs to the level of and exceeds the tested 800 mg (0.8 g) loading of naltrexone in an implant with no program or therapy. There also is no discussion of the required elements of the program delivered by the licensed professional to attain the BMI reduction outcome at the prescribed time points of instant claims 28-30 when paired with the naltrexone delivery. Naltrexone has been seen to have impacts on weight gain reduction under circumstances associated with weight gain in women, even after administration has stopped (see King et al. Biological Psychiatry 2013 73:924–930; page 927 first column last partial paragraph). However, there is no indication of the necessary dosing kinetics, device configuration, or clinician administered counseling/therapy program that achieves the required degree of BMI reduction at the claimed 8 week and 12 week post implantation timepoints. As a result, the claims are lacking a sufficient structure-function correlation to be adequately described and the artisan of ordinary skill would not have deemed them to be in possession of the claimed invention at the time of filing.
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 21-32, 34, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over McKinney et al. (US PGPub No. 2007/0129283) in view of Goonoo et al. (Journal of Controlled Release 2014 183:154-166), Farra et al. (Science Translational Medicine 2012 4(122)(ra21):1-10), Sidman (US Patent No. 4,351,337), Saxena et al. (US PGPub No. 2018/0338925), McKinney et al. (US Patent No. 8,916,195 - henceforth McKinney B), McElroy et al. (Primary Care Companion CNS Disorders 2013 15(3):e1-e8), and Wai et al. (The Spine Journal 2008 8:195-202) as evidenced by Hyde et al. (US PGPub No. 2009/0240241).
McKinney et al. teach the reduction of food cravings to invoke weight loss by the administration of opioid antagonist and a a-melanocyte stimulating hormone (see abstract and paragraphs 23 and 71; 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 this 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 25-28 and 30). Determination of this degree of loss implicitly requires measuring the weight and determining in 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 above 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). This range overlaps with that instantly claimed, thereby rendering the claim 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). 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 (see paragraphs 21 and 117 and figure 2). They further teach the implants to produce a blood concentration of greater than 1 ng/ml 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). This narrow dosage range embraces the instantly claimed values and overlaps the instantly claimed range, thereby rendering these claimed limitations obvious (see MPEP 2144.05; instant claims 21 and 32, and 34). Saxena et al. teach the lower abdomen as the region for subcutaneous implantation (see paragraph 31; instant claim 21).
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 in order to yield the same improvement. Further, it would have been obvious to implant the device subcutaneously in the lower abdominal region above the muscle fascia and load with naltrexone amounts as taught by Saxena et al. and Farra et al. These choices would have been obvious because they teach this location as suitable for drug delivery and they teach achieving similar blood concentration levels of naltrexone as the sustained release orally administered naltrexone of McKinney B. Thus the implantation of the implants with 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 25-30 and 36 merely characterize the results of those steps. Therefore, it is determined that the "wherein" clause is not entitled to weight in construing the claim. Further, it would have been obvious to measure the BMI of the subject subsequent to implantation in order to assess whether they are obese, overweight, or of normal weight because the method was initiated to lose weight and achieve a healthier or normal weight (see instant claim 31). Adjustment to the rate of weight loss would then follow in accordance with the suggestion by McKinney et al. to adjust this rate as desired (see instant claims 25-30). 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. Therefore claims 21-32, 34, and 36 are obvious over McKinney et al. in view of Goonoo et al., Farra et al., Sidman, Saxena et al., McKinney B, McElroy et al., and Wai et al. as evidenced by Hyde et al.
Claims 21-36 are rejected under 35 U.S.C. 103 as being unpatentable over McKinney et al. in view of Goonoo et al., Farra et al., Sidman, Saxena et al., McKinney B, McElroy et al., and Wai et al. as evidenced by Hyde et al. as applied to claims 21, 23-30, 34, 37-39, and 42 above, and further in view of O’Neill et al. (US PGPub No. 2003/0170305).
McKinney et al. in view of Goonoo et al., Farra et al., Sidman, Saxena et al., McKinney B, McElroy et al., and Wai et al. as evidenced by Hyde et al. render obvious the limitations of instant claims 21-32, 34, and 36, but do not explicitly teach administering an implant with 2.2 g or 4 g of naltrexone.
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). 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). 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 1 to 20 g (see paragraphs 31 and 34). 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).
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 loading amounts of naltrexone as taught by O’Neill et al. in the implant set employed in the modified method of McKinney et al. This modification would have been obvious because it embraces the range employed in the Saxena et al. implants employed in the modified method and provides a similar level of daily naltrexone in the blood. The narrow dosage range of O’Neill et al. embraces the instantly claimed values and overlaps with the instantly claimed range, thereby rendering these claimed limitations obvious (see MPEP 2144.05). The discrete values disclosed by O’Neill et al. are the same as or nearly the same as those instantly claimed, fall within the 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 as well. Therefore claims 21-36 are obvious over McKinney et al. in view of Goonoo et al., Farra et al., Sidman, Saxena et al., McKinney B, McElroy et al., Wai et al., and O’Neill et al.as evidenced by Hyde et al.
Claims 21-32, 34, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over McKinney et al. in view of Goonoo et al., Farra et al., Sidman, Saxena et al., McKinney B, McElroy et al., and Wai et al. as evidenced by Hyde et al. as applied to claims 21-32, 34, and 36 above, and further in view of Amirouche et al. (WO 2013/158430).
McKinney et al. in view of Goonoo et al., Farra et al., Sidman, Saxena et al., McKinney B, McElroy et al., and Wai et al. as evidenced by Hyde et al. render obvious the limitations of instant claims 21-32, 34, and 36. The angle of insertion into the subcutaneous region is not detailed.
Amirouche et al. teach a 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 suitable for the subcutaneous implantation in the modified method of McKinney et al. Thus a 45⁰ angle as taught by Amirouche et al. would have been obvious to utilize. Therefore claims 21-32, 34, and 36-37 are obvious over McKinney et al. in view of Goonoo et al., Farra et al., Sidman, Saxena et al., McKinney B, McElroy et al., Wai et al., and Amirouche et al. as evidenced by Hyde et al.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16 and 21 of copending Application No. 18/270682 (reference application) in view of Farra et al., Sidman, Saxena et al., McElroy et al., and Wai et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite treating a patient with a BMI over 25. The copending claims recite treating obesity which corresponds to a BMI of over 30 (see Clark paragraph 230). Treatment occurs via subcutaneous implantation of a naltrexone releasing implant. The copending claims recite releasing 150 mg to 2g of naltrexone. The release duration, precise implant location, and licensed profession delivered program are not detailed by the copending claims.
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 above in a subcutaneous pocket above the muscle fascia (see page 8 second column third full paragraph; instant claim 21).
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). This range overlaps with that instantly claimed, thereby rendering the claim 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). 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 (see paragraphs 21 and 117 and figure 2). They further teach the implants to produce a blood concentration of greater than 1 ng/ml 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). This narrow dosage range embraces the instantly claimed values and overlaps the instantly claimed range, thereby rendering these claimed limitations obvious (see MPEP 2144.05; instant claims 21 and 32, and 34). Saxena et al. teach the lower abdomen as the region for subcutaneous implantation (see paragraph 31; instant claim 21).
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 obese patients with the subcutaneously implanted naltrexone as detailed in the copending claims because they state to do so. The loading and release amounts of naltrexone instantly claimed overlaps with or are embraced by that of the copending claims, thereby rendering the claimed amounts obvious (see MPE 2144.05). Further, it would have been obvious to implant the device subcutaneously in the lower abdominal region above the muscle fascia and load with naltrexone amounts as taught by Saxena et al. and Farra et al. These choices would have been obvious because they teach this location as suitable for drug delivery from subcutaneous implants. Thus the implantation of the implants with the 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 25-30 and 36 merely characterize the results of those steps. Therefore, it is determined that the "wherein" clause is not entitled to weight in construing the claim. Further, it would have been obvious to measure the BMI of the subject subsequent to implantation in order to assess whether they are obese because the method was initiated treat obesity (e.g., lose weight and achieve a healthier or normal weight; instant claim 31). Adjustment to the rate of weight loss would then follow as desired by the patient/ licensed professional (see instant claims 25-30). 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 copending method to further support their goal of weight loss because the combination of drugs and the desired outcome in the modified copending claims 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 the copending claims 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. Therefore claims 21-36 are obvious over claims 16 and 21 of copending Application No. 18/270682 in view of Farra et al., Sidman, Saxena et al., McElroy et al., and Wai et al.
Claims 21-37 are rejected under 35 U.S.C. 103 as being unpatentable over claims 16 and 21 of copending Application No. 18/270682 in view of Farra et al., Sidman, Saxena et al., McElroy et al., and Wai et al. as evidenced by Hyde et al. as applied to claims 21-36 above, and further in view of Amirouche et al.
Claims 16 and 21 of copending Application No. 18/270682 in view of Farra et al., Sidman, Saxena et al., McElroy et al., and Wai et al. render obvious the limitations of instant claims 21-36. The angle of insertion into the subcutaneous region is not detailed.
Amirouche et al. teach a 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 suitable for the subcutaneous implantation in the modified method of the copending claims. Thus a 45⁰ angle as taught by Amirouche et al. would have been obvious to utilize. Therefore claims 21-37 are obvious over claims 16 and 21 of copending Application No. 18/270682 in view of Farra et al., Sidman, Saxena et al., McElroy et al., Wai et al., and Amirouche et al.
These are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed August 26, 2025 have been fully considered. In light of the amendment to the claims canceling all previous claims and introducing all new claims are moot. New grounds of rejection are detailed to address the new claims.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
/MELISSA S MERCIER/Primary Examiner, Art Unit 1615