Commissioner’s Decision #1519
Décision du commissaire #1519
TOPICS: O00 Obviousness
SUJETS: O00 Évidence
Application no. 2,517,102
Demande no 2 517 102
IN THE CANADIAN PATENT OFFICE
DECISION OF THE COMMISSIONER OF PATENTS
Patent application number 2,517,102, having been rejected under subsection 30(3) of the Patent Rules (SOR/96-423) as they read immediately before October 30, 2019, has consequently been reviewed in accordance with paragraph 199(3)(c) of the Patent Rules (SOR/2019-251). The recommendation of the Board and the decision of the Commissioner are to withdraw the rejection and allow the application.
Agent for the Applicant
TORYS LLP
79 Wellington St. West
30th Floor
Box 270, TD South Tower
TORONTO Ontario
M5K 1N2
INTRODUCTION
[1] This recommendation concerns the review of rejected Canadian patent application number 2,517,102 (“the instant application”), which is entitled “KIT FOR PHARMACEUTICAL USE” and is owned by ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED (“the Applicant”). A review of the rejected application has been conducted pursuant to paragraph 199(3)(c) of the Patent Rules. As explained in more detail below, our recommendation is that the Commissioner of Patents withdraw the rejection and allow the application.
BACKGROUND
The Application
[2] The instant application was filed in Canada on March 26, 2004 under the provisions of the Patent Cooperation Treaty and was laid open to public inspection on October 14, 2004. The application claims priority from a corresponding United States patent application filed on March 26, 2003.
[3] The instant application relates to a kit used by a patient in a treatment regimen that uses a bone resorption-inhibiting drug and a nutrient supplement, such as in the treatment of osteoporosis. In particular, it relates to a blister card comprising a unit dosage of a particular type of bone resorption-inhibiting drug known as “risedronate” to be taken on a once-weekly basis and multiple unit dosages of a nutrient supplement comprising calcium that are to be taken on the days when the drug is not taken. The dosages of risedronate and nutrient supplements are arranged in a blister card format such that proper sequential oral administration of the dosages by the patient is promoted, thereby achieving better patient compliance with the treatment regimen while avoiding undesirable interactions between the risedronate drug and the nutrient supplement.
[4] Figure 1 of the instant application, set out below, illustrates a basic form of the claimed invention with cavity 10 on the blister card being where the risedronate dosage is contained and cavities 11 being where the nutrient supplement dosages are contained. The back of the blister card, as shown in Figure 2 below, contains printed memory aids to help the patient adhere to the regimen.
Prosecution History
[5] On November 30, 2016, a Final Action (“FA”) was written pursuant to subsection 30(4) of the Patent Rules as they read immediately before October 30, 2019. The FA stated that the instant application is defective on the ground that all of the claims 1-5 on file at the time of the FA (“claims on file”) would have been obvious and therefore do not comply with section 28.3 of the Patent Act.
[6] In a May 30, 2017 response to the FA (“R-FA”), the Applicant submitted arguments in favour of the claims on file but did not propose amendments to them.
[7] As the Examiner considered the application not to comply with the Patent Act and Patent Rules, the application was forwarded to the Patent Appeal Board (“the Board”) for review on February 9, 2018 along with an explanation outlined in a Summary of Reasons (“SOR”). The SOR set out the position that the claims on file were still considered to be defective due to obviousness.
[8] In a letter dated February 15, 2018, the Board forwarded to the Applicant a copy of the SOR and requested that the Applicant confirm its continued interest in having the application reviewed.
[9] In a letter dated May 14, 2018, the Applicant confirmed its interest in having the review proceed.
[10] The present panel (“the Panel”) was formed to review the instant application under paragraph 199(3)(c) of the Patent Rules.
[11] Given our recommendation that the rejection be withdrawn and the application allowed, no further written or oral submissions from the Applicant are necessary.
ISSUE
[12] The issue to be addressed by the present review is whether claims 1-5 on file would have been obvious, contrary to section 28.3 of the Patent Act.
LEGAL PRINCIPLES AND OFFICE PRACTICE
Claim Construction
[13] In accordance with Free World Trust v Électro Santé Inc, 2000 SCC 66, essential elements are identified through a purposive construction of the claims done by considering the whole of the disclosure, including the specification and drawings (see also Whirlpool Corp v Camco Inc, 2000 SCC 67 at paras 49(f) and (g) and 52). In accordance with the Manual of Patent Office Practice, §12.02 (revised June 2015), the first step of purposive claim construction is to identify the person skilled in the art and their relevant common general knowledge (“CGK”). The next step is to identify the problem addressed by the inventors and the solution put forth in the application. Essential elements can then be identified as those required to achieve the disclosed solution as claimed.
Obviousness
[14] The Patent Act requires that the subject-matter of a claim not be obvious to a person skilled in the art. Section 28.3 of the Patent Act states:
28.3 The subject-matter defined by a claim in an application for a patent in Canada must be subject matter that would not have been obvious on the claim date to a person skilled in the art or science to which it pertains, having regard to
(a) information disclosed more than one year before the filing date by the applicant, or by a person who obtained knowledge, directly or indirectly, from the applicant in such a manner that the information became available to the public in Canada or elsewhere; and
(b) information disclosed before the claim date by a person not mentioned in paragraph (a) in such a manner that the information became available to the public in Canada or elsewhere.
[15] In Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61 [Sanofi] at paragraph 67, the Supreme Court of Canada stated that it is useful in an obviousness inquiry to use the following four-step approach:
(1) (a) Identify the notional “person skilled in the art”;
(b) Identify the relevant common general knowledge of that person;
(2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;
(3) Identify what, if any, differences exist between the matter cited as forming part of the “state of the art” and the inventive concept of the claim or the claim as construed;
(4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?
[16] In the context of the fourth step, the Court in Sanofi stated that it may be appropriate in some cases to consider an “obvious to try” analysis. For a finding that an alleged invention is “obvious to try”, it must be more or less self-evident to try to obtain the alleged invention in advance of routine testing. The mere possibility that something might work is not sufficient.
[17] The Court in Sanofi listed the following non-exhaustive factors to be considered in an “obvious to try” analysis:
(1) Is it more or less self-evident that what is being tried ought to work? Are there a finite number of identifiable predictable solutions known to persons skilled in the art?
(2) What is the extent, nature and amount of effort required to achieve the invention? Are routine trials carried out or is the experimentation prolonged and arduous, such that the trials would not be considered routine?
(3) Is there a motive provided in the prior art to find the solution the patent addresses?
[18] The Court in Sanofi set out a further factor to be considered, namely the course of conduct that culminated in the making of the invention.
[19] Obviousness has been described as a difficult test to satisfy (Beloit Canada Ltd v Valmet Oy (1986), 8 CPR (3d) 289 [Beloit]:
The test for obviousness is not to ask what competent inventors did or would have done to solve the problem. Inventors are by definition inventive. The classical touchstone for obviousness is the technician skilled in the art but having no scintilla of inventiveness or imagination; a paragon of deduction and dexterity, wholly devoid of intuition; a triumph of the left hemisphere over the right. The question to be asked is whether this mythical creature (the man in the Clapham omnibus of patent law) would, in the light of the state of the art and of common general knowledge as at the claimed date of invention, have come directly and without difficulty to the solution taught by the patent. It is a very difficult test to satisfy.
ANALYSIS
Claim Construction
[20] The invention provides a kit for simplifying the administration of a treatment regimen comprising a bisphosphonate, in particular risedronate, when combined with a nutrient, the goal of which is to increase patient compliance with the treatment regimen. Independent claim 1 on file reads as follows:
1. A kit for promoting the proper sequential oral administration of a unit dose of bisphosphonate and of an accompanying nutrient on the days in between the days when the unit dose of the bisphosphonate is taken, said kit comprising:
(a) at least one unit dose of a bisphosphonate to be given continuously on frequency of once a week;
(b) at least one unit dose of a nutrient that is calcium, calcium and vitamin D, or a combined unit dose of calcium and vitamin D to be given subsequent to the bisphosphonate administration and on the days in between the days when the unit dose of the bisphosphonate is taken; and
(c) at least one blister card individually and releasably containing the unit doses of the bisphosphonate and the nutrient;
wherein the blister card is consisting essentially of one, two or four horizontal or vertical rows of unit doses, and wherein each row is characterized by one unit dose of the bisphosphonate and six or twelve unit doses of the nutrient,
wherein simultaneous daily dosing of the bisphosphonate and the nutrient is avoided,
wherein the bisphosphonate is risedronate.
[21] Dependent claims 2-4 set forth further refinements of claim 1.
[22] Claim 5 defines a use of the kit according to any one of claims 1-4.
[23] In the present case, there are no issues as to the meaning or scope of any terms in the claims on file, nor were there any questions raised as to the essentiality of any of the elements of the claims. As such, we take all of the elements of the claims into account in assessing their obviousness below.
Obviousness
(1)(a) Identify the notional “person skilled in the art”
[24] In the FA at page 4, the person skilled in the art was characterized as “a pharmaceutical package manufacturer.”
[25] In the R-FA at page 3, the Applicant submitted that the person skilled in the art is “a technician with experience in the manufacture of pharmaceutical packaging.”
[26] In our view, although a kit is claimed comprising an arrangement of an active ingredient and a nutrient, these elements result from the underlying treatment regimen that is also set out in the claims on file. As described on page 1 of the instant application, the invention relates to kits that are “useful for treatment regimens wherein the active ingredient is administered on a continuous frequency other than daily and the nutrient is administered on the days in between the days the active ingredient is administered.” Also, the Background of the Invention in the instant application discusses types of kits that have been developed to address patient compliance issues with treatment regiments. Further, the focus of the claimed subject-matter is on the use of a kit comprising bisphosphonate, in particular, risedronate, that is used in a treatment regimen.
[27] In our view, given the importance of the underlying treatment regimen and the nature of the active ingredient, the person skilled in the art is best characterized as a person skilled in treatment regimens that use bisphosphonates, such as the treatment of osteoporosis, with experience in pharmaceutical packaging.
(1)(b) Identify the relevant common general knowledge of that person
[28] In the FA at page 4, the relevant CGK was set out as follows:
The person skilled in the art would be expected to possess the common general knowledge relating to such a manufacturer. In particular, the kit having a pharmaceutical active and a nutrient such that the unit doses are arranged vertically/horizontally across the blister card for proper use and the specific number of unit doses of either the pharmaceutical active/nutrient is known before the priority date of the alleged invention.
[29] In the R-FA at page 3, the Applicant conceded that the person skilled in the art would have knowledge of kits for the administration of an active ingredient on a once-weekly basis. However, the Applicant also asserted that:
…a person skilled in the art would not have knowledge of kits designed or intended to address compliance issues associated with the continuous administration of a pharmaceutical active on a frequency other than daily taken together with a separate nutrient on the days in between the days the active ingredient is administered, and in which separately taking the pharmaceutical active and the nutrient is done in order to avoid interference between the two. [Emphasis in original]
[30] In our view, the person skilled in the art would not have knowledge of a kit comprising a pharmaceutically active ingredient and an associated nutrient that are set out in a blister card so as to ensure patient compliance. The FA cited no basis for this point and we see none in the Background of the Invention discussion of the instant application.
[31] However, in our view, the following points of CGK may be taken from our above definition of the person skilled in the art and the information in the Background of the Invention portion of the instant application:
• knowledge of well-known treatment regimens using bisphosphonates, including treatment regimens for osteoporosis;
• knowledge of the use of prepared blister cards that reflect a prescribed treatment regimen;
• knowledge of treatment regimens that require nutrient supplements for maximum efficiency of the active ingredients;
• knowledge of patient compliance issues associated with varying dosage timing or conditions for active ingredient/nutrient regimens;
• knowledge of kits designed to dispense active ingredients on a continuous daily frequency or a once weekly basis; and
• knowledge of kits designed to administer multiple doses of the same active ingredient per day or for concurrent or non-concurrent administration of two or more active ingredients.
[32] We note that the points above are consistent with those identified in the declaration of Dr. Fabian Somers submitted with the R-FA.
[33] During the review of the instant application, the Panel considered the following articles, which we consider to be representative of the relevant CGK insofar as osteoporosis treatment is concerned:
• Brown et al.(1). 2002 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada, Canadian Medical Association Journal, November 12, 2002; 167 (10 suppl);
• Brown et al.(2). The Efficacy and Tolerability of Risedronate Once a Week for the Treatment of Postmenopausal Osteoporosis, Calcified Tissue International, June 27, 2002, 71:103-111;
• Gordon et al. Response of Bone Mineral Density to Once-Weekly Administration of Risedronate, Endocrine Practice, Vol 8, No. 3, May/June 2002; and
• Chapurlat et al. Risedronate: Clinical Usage, International Journal of Clinical Practice, May 2001, Vol 55, No. 4.
[34] Brown et al. (1) is a review article resulting from an extensive literature review undertaken to update clinical practice guidelines for the treatment of osteoporosis. In particular, Brown et al. (1) disclose at page S14 that risedronate, one of the bisphosphonates discussed therein, has been shown to be effective at reducing both vertebral and non-vertebral fractures in women with postmenopausal osteoporosis using both daily and once-weekly treatments regimens:
Many studies have demonstrated risedronate efficacy, using both daily and once-weekly treatment regimens. Recently, 2 large, 3-year, multicentre RCTs evaluated the efficacy of risedronate in the treatment of postmenopausal osteoporosis. After 3 years of treatment at 5 mg/day, risedronate reduced the incidence of vertebral fractures by 41–49% and non-vertebral fractures by 39–33%. [Citations omitted]
[35] Brown et al. (1) also reviewed the use of non-pharmacologic interventions, including the use of calcium and vitamin D supplements. Brown et al. (1) note at page S23 that the daily intake of calcium and vitamin D through diet or supplements is an essential adjunct to osteoporosis treatment:
Calcium and vitamin D should not be used as the sole treatment of osteoporosis; however, calcium and vitamin D through diet or supplements are essential adjuncts to osteoporosis treatment. [Citations omitted]
[36] Brown et al. (2) disclose a study to evaluate the efficacy and tolerability of risedronate given once-weekly and once-daily. Both were found to be effective treatments. The subjects received daily calcium supplements and were told not to take the supplement with the study drug (Brown et al. (2) at page 104). However, no explanation is provided for the warning associated with the supplement intake:
All participants received a calcium supplement equivalent to 1000 mg of elemental Ca daily, to be taken with lunch or the evening meal. Subjects were told not to take the Ca supplement with the study drug.
[37] Gordon et al. disclose the results of a study to determine the changes in bone mineral density and tolerability associated with a once-weekly dosage of risedronate. All patients were also given supplemental daily calcium and vitamin D, with the vitamin D being typically given weekly, biweekly or monthly (Gordon et al. at page 203). The results indicated increased bone mineral density and few adverse side effects.
[38] Chapurlat et al., in an article discussing the clinical usage of risedronate, discuss the known practical usage of it, which comprises a daily dosage that can be accompanied by calcium, aluminum and magnesium containing supplements. However, the authors, at page 277, caution against taking the supplements with the risedronate:
Calcium-, aluminium- and magnesium-containing medications may interfere with the absorption of risedronate and should be taken at a different time of the day.
[39] Collectively, we take from the above sources that at the claim date of the instant application:
• Both once-daily and once-weekly dosages of the bisphosphonate drug risedronate for the treatment of osteoporosis were well accepted;
• Daily intake of calcium and vitamin D through diet or supplements was an essential adjunct to an osteoporosis prevention and treatment regimen; and
• While supplements such as calcium and vitamin D were an important part of a prevention and treatment regimen, there were indications that such supplements interfered with the absorption of the active ingredient and suggestions that the supplements not be taken concurrently with the active ingredient
[40] In our view, what was not well-known at the claim date to the skilled person was the use of a once-weekly dosage of risedronate combined with the intake of calcium or calcium and vitamin D supplements only on the days between risedronate dosages. The CGK merely suggests not taking the supplements at the same time of day as risedronate; it does not suggest completely avoiding their use on the same day as when risedronate is to be taken.
(2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it
[41] In the FA at page 4, the inventive concept was identified as:
a kit comprising a blister card of a combination of a bisphosphonate (risedronate) and a nutrient (calcium or vitamin D or both) arranged for promoting proper oral administration.
[42] In the R-FA at pages 3-4, the Applicant contends that the assessment of obviousness should be undertaken based on the subject-matter of the claims as construed. In particular, the Applicant lists all the elements of claim 1 on file as what should be assessed.
[43] In our view, though the FA summarized the subject-matter of the claims on file in the identification of the inventive concept, all the elements of the claims were considered in Sanofi steps (3) and (4). We will proceed in the same manner below.
(3) Identify what if any differences exist between the matter cited as forming part of the “state of the art” and the inventive concept of the claim or the claim as construed
[44] In the FA, the claims on file were considered to have been obvious based on the three prior art documents listed below:
D1: US 5,366,965 Strein November 22, 1994
D2: US 5,994,329 Daifotis et al. November 30, 1999
D3: US 4,812,311 Uchtman March 14, 1989
[45] D1 discloses methods for treating or preventing osteoporosis comprising bone resorption inhibiting bisphosphonates, including risedronate (D1 at col. 4, lines 42-43). D1 discloses the administration of the drug in at least two cycles, with each cycle comprising an inhibiting period during which the drug is administered, followed by a rest period during which it is suggested that a placebo or a beneficial nutrient supplement may be administered (D1 at col. 3, line 62 to col. 4, line 19 and col. 5, lines 44-65). The inhibiting period can vary, but is most preferably 14 days, with each inhibiting period comprising most preferably two intermittent periods. The drug is administered on only one day during each intermittent period. Essentially, the drug would most preferably be administered once a week for two weeks. D1 discloses variations on the period lengths but the drug administration structure is the same. During the inhibiting period, only the drug is administered. The rest period follows the inhibiting period and this is when nutrient supplements may be taken. But there is no intake of nutrient supplements disclosed between the most preferable once a week administration of the drug during the inhibition period, as is the case in claim 1 on file.
[46] Contrary to the view expressed in the FA at page 3 that D1 disclosed the administration of the nutrient supplements on the days in between the days on which the active drug was to be taken, in our view, D1 discloses separate periods for multiple administrations of the active drug and the possible nutrient supplements. During the rest periods, no active drug is taken by the patient and these rest periods follow inhibition periods during which the active drug is taken at least twice over most preferably a 14 day period. This is in contrast to claim 1 on file, in which a nutrient supplement would be taken between dosages of the drug. In D1, risedronate would be administered most preferably once a week for two weeks with a subsequent rest period (most preferably 75-80 days) during which a nutrient supplement could be taken. It is also clear from D1 that no importance is attached to the inclusion of a nutrient supplement in the treatment regimen, the alternative being a placebo.
[47] While D1 discloses the provision of a kit that reflects the dosage regimen disclosed therein, it does not disclose or suggest an administration regimen, such as that of claim 1 on file, where a nutrient supplement is taken on the days between each intake of the risedronate, itself administered once a week. It follows that D1 does not disclose or suggest a kit reflective of such a regimen.
[48] D2 discloses methods for inhibiting bone resorption in mammals that include the use of risedronate. D2 suggests various dosing regimens, including once-weekly, twice-weekly, biweekly and twice-monthly. D2 also suggests the use of kits for delivery of the drug and suggests the use of numbers, letters, markings or calendar inserts as memory aids to designate the days on which the active dosage can be taken (D2 at col. 13, lines 48-67). As an alternative to such memory aids, D2 suggests the use of placebo dosages or calcium or dietary supplements on days between the intake of the bone resorption inhibiting compound, to thereby provide a dosage that can be taken every day. However, in our view, the skilled person would view the inclusion of the nutrient supplements in D2 as purely optional, rather than a required part of the treatment regimen. The suggested alternatives of a placebo or markings on the kit itself reinforce this view.
[49] D3 discloses a kit for use in a regimen for treatment or prevention of osteoporosis. The regimen disclosed generally consists of three stages: a bone activating period; a bone resorption inhibition period; and a rest period (D3 at col. 3, lines 25-29). The clinical tests disclosed therein used multiple daily doses of a bone activating compound, followed by multiple daily doses of a bone resorption-inhibiting compound, followed by an extended rest period (73 days) during which calcium levels were monitored (D3 at col. 9, line 48 to col. 10, line 4). D3 broadly contemplates a single dosage of the bone activation compound before the next regimen stage as part of the treatment regimen, but not a single dose of the bone resorption-inhibiting compound, with claim 1 of D3 specifying from about 10 to 20 daily dosages of the bone resorption-inhibiting compound during the second stage. D3 indicates that it is desirable to administer food supplements such as calcium or vitamin D during the rest period, to ensure optimum conditions for bone formation (col. 3, lines 35-38 and col. 6, lines 54-57), but suggests that this is unnecessary, since a placebo may be administered instead.
[50] In our view, the regimen in D3 is similar to that disclosed by D1 where there are multiple dosages of a bone resorption-inhibiting compound administered over multiple days, followed by a rest period where a placebo or nutrient supplement may be administered. There is no disclosure or suggestion of a once-weekly dosage of the bone resorption-inhibiting compound with a nutrient supplement being administered on the days between the once-weekly dosages.
[51] Overall, based on D1-D3, there is no disclosure of a treatment regimen wherein a bisphosphonate such as risedronate is administered once-weekly, with a nutrient such as calcium or calcium and vitamin D being administered only on the days between the bisphosphonate treatment, as specified in claim 1 on file. We agree with the Applicant’s position in the R-FA where the Applicant describes the addition of nutrient supplements in D1-D3 as having been a mere possibility or optional.
[52] The Applicant contends that D1-D3 are deficient in that they do not recognize a problem in the field of osteoporosis treatment, the problem being calcium interfering with the absorption of the bisphosphonate when they are taken at the same time. Dr. Somers in his declaration also contends that D1-D3 are deficient in that they do not recognize the specific problem of calcium interfering with the absorption of bisphosphonate. We note that there is no calcium interference problem recited in the claims. However, it will be considered as an obviousness factor at step (4).
(4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?
[53] Unlike the position taken in the FA and discussed above at step (3), we do not agree that the treatment regimen that serves as a basis for the arrangement of dosages in the kit blister card of claim 1 is disclosed by the prior art documents D1-D3. While the FA contended that the only difference was the specific arrangement of the dosage on a blister card, our view is that the difference is more significant, as noted above.
[54] In the R-FA at page 7, the Applicant contends that the mere possibility of including nutrients as part of a treatment regimen using a bisphosphonate is not sufficient to bridge the gap between the claims and the prior art.
[55] We agree with the Applicant and, in our view, the gap between the prior art and the claims cannot be bridged by the relevant CGK. While once-weekly dosages of risedronate to treat osteoporosis were part of the relevant CGK at the claim date, as were daily dosages, and it was part of the relevant CGK that daily intake of calcium and vitamin D through diet or supplements were essential adjuncts to such a treatment regimen, this would not in our view lead the skilled person directly and without difficulty (Beloit, supra) to the claimed kit that embodies the underlying dosage regimen. The relevant CGK and the prior art show the once-weekly dosage format, but also disclose a daily dosage format, so to arrive at the claimed kit the skilled person must first choose the once-weekly regimen. The guidance on the use of nutrient supplements provided by the prior art and relevant CGK would not, in our view, directly lead the skilled person to use them with a risedronate treatment regimen, since dietary intake was a possible alternative. The skilled person would be guided to avoid using the calcium supplement at the same time of day as the risedronate, due to concerns about interference with it, a problem not first recognized by the Applicant. However, in our view, the skilled person would not be led to discontinue using nutrient supplements on the day when risedronate is to be taken. The relevant CGK and prior art simply show the use of nutrient supplements at times of the day different than when the bisphosphonate is to be taken.
[56] At best, there is guidance that such nutrient supplements may be used in association with a bisphosphonate treatment regimen, but not specifically how, other than a calcium supplement should not be taken at the same time. Some of the prior art, in particular D2, may be seen to suggest the use of a nutrient supplement on days other than those on which the bisphosphonate is taken, but given the purely optional nature of the nutrient supplement use in the prior art, in our view, this would not be sufficient to lead the skilled person to the claimed treatment regimen and kit.
[57] We note that the FA made reference to the “obvious-to-try” assessment set out in Sanofi at paras [69]-[71], but provided no analysis of the factors involved. We also note that the Applicant made no specific submissions in response. In any case, we are of the view that the claimed regimen and kit was not more or less self-evident based on the analysis above and that there was no specific motivation that would have led the skilled person to it. The relevant CGK indicates general issues with patient compliance for treatment regimens involving nutrient supplements and issues of interference of calcium supplements with bisphosphonate absorption, but this guidance is too general to have motivated the skilled person to arrive at the claimed regimen. With regard to the other obvious-to-try factors, namely the effort required to achieve the invention and the course of conduct of the inventor, we have no evidence to consider.
[58] In light of the above, it is our view that claim 1 on file would not have been obvious and is therefore compliant with section 28.3 of the Patent Act. Likewise, since claims 2-4 directly or indirectly depend on claim 1, they too would not have been obvious and are therefore compliant with section 28.3 of the Patent Act. Claim 5, directed to the use of the kit according to any one of claims 1-4, would also not have been obvious.
CONCLUSIONS
[59] We have determined that claims 1-5 on file would not have been obvious and are therefore compliant with section 28.3 of the Patent Act.
RECOMMENDATION OF THE BOARD
[60] For the reasons set out above, we are of the view that the rejection is not justified on the basis of the defect indicated in the Final Action notice and we have reasonable grounds to believe that the instant application complies with the Patent Act and the Patent Rules. We recommend that the Applicant be notified in accordance with subsection 86(10) of the Patent Rules that the rejection of the instant application is withdrawn and that the instant application has been found allowable.
Stephen MacNeil Paul Fitzner Ed MacLaurin
Member Member Member
DECISION
[61] I concur with the conclusions and recommendation of the Board. In accordance with subsection 86(10) of the Patent Rules, I hereby notify the Applicant that the rejection of the instant application is withdrawn, the instant application has been found allowable and I will direct my officials to issue a Notice of Allowance in due course.
Johanne Bélisle
Commissioner of Patents
Dated at Gatineau, Quebec,
this 12th day of February, 2020.