DETAILED ACTION
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
The serotonin receptor 1F (HTR1F) antagonist.
Applicant is required, in reply to this action, to elect a single compound species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: Claims 1, 2, 3, 5, 13 and 17.
The species listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Where a single claim defines alternatives of a Markush group, the requirement of a technical interrelationship and the same or corresponding special technical features as defined in Rule 13.2, is considered met when the alternatives are of a similar nature. When the Markush grouping is for alternatives of chemical compounds, the alternatives are regarded as being of a similar nature where the following criteria are fulfilled:
(A) all alternatives have a common property or activity; AND
(B)(1) a common structure is present, that is, a significant structural element is shared by all of the alternatives; OR
(B)(2) in cases where the common structure cannot be the unifying criteria, all alternatives belong to a recognized class of chemical compounds in the art to which the invention pertains.
The phrase “significant structural element is shared by all of the alternatives” refers to cases where the compounds share a common chemical structure which occupies a large portion of their structures, or in case the compounds have in common only a small portion of their structures, the commonly shared structure constitutes a structurally distinctive portion in view of existing prior art, and the common structure is essential to the common property or activity.
The phrase “recognized class of chemical compounds” means that there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention, i.e. each member could be substituted one for the other, with the expectation that the same intended result would be achieved.
In this case, the chemical compounds embraced by “a serotonin receptor 1F (HTR1F) antagonist” are not regarded as being of similar nature because: (1) the alternatives do not all share a common core structure and (2) the alternatives do not all belong to a recognized class of chemical compounds. For example, “HTR1F antagonist” embraces methiothepin, methsergide and derivatives thereof, and antibodies that bind to HTR1F, nucleic acids that inhibit HTR1F, as well as a compound according to the genus of Formula I, each of which necessitates different search strategy and parameters and belongs to a different class/ subclass.
During a telephone conversation with Peter Piers on September 25, 2025, a provisional election was made without traverse to prosecute the invention of the species of Figure 5:
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1-(2-hydroxy-3-(naphthalen-2-yloxy)propyl)-4-(quinolin-3-yl)piperidin-4-ol.
Affirmation of this election must be made by applicant in replying to this Office action.
The non-elected compound species of HTR1F antagonist are presently withdrawn from consideration, i.e., claims 9-11 and 22-23 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-8, 12-21 and 24 are under examination with the elected species and are the subject of this office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 18, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings submitted July 10, 2023 are objected to because in Figure 1A, the design is blurry and some text is difficult to read. In Figures 1B and 1C, the lines representing each donor are difficult to distinguish. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112(b)
8. 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.
9. Claims 3, 4, 13-20 and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
10. Claim 3 is drawn to claim 1 and recites the limitation “wherein the HTR1F antagonist is administered to the subject in conjunction with a pancreatic islet transplantation,” which is confusing because it is not clear what is meant from the claim “in conjunction with.” For example, has the diabetic patient previously received a pancreatic islet transplantation prior to treatment, or is the HTR1F antagonist administered to the subject simultaneously/ concurrently with a pancreatic islet transplantation, or are the islet cells treated with the HTR1F antagonist prior to transplantation in the subject, or a combination of some/ all of the above. Clarification is requested.
In view of a broadest reasonable interpretation, the recitation of “in conjunction with pancreatic islet transplantation” is construed to mean:
The method of claim 1, wherein the subject in need thereof is additionally treated with a pancreatic islet cell transplantation, wherein the islet cells are treated with said HTR1F antagonist prior to transplantation.
11. Claim 4 is rejected as being dependent upon and including all of the limitations of claim 3.
12. Claim 13 recites a method for transplanting pancreatic islets to a subject comprising delivering pancreatic islets to the subject in conjunction with an HTR1F antagonist, which is confusing because it is not clear what is meant from the claim “in conjunction with.” For example, has the subject previously received an HTR1F antagonist, prior to pancreatic islet transplantation, or is the HTR1F antagonist administered to the subject simultaneously/ concurrently with a pancreatic islet transplantation, or are the islet cells treated with the HTR1F antagonist prior to transplantation in the subject, or a combination of some/ all of the above. Clarification is requested.
In view of a broadest reasonable interpretation, the recitation of “in conjunction with an HTR1F antagonist” is construed to mean:
A method of treating a subject comprising transplanting pancreatic islet cells to said subject, wherein the islet cells are treated with an HTR1F antagonist prior to transplantation.
13. Claims 14-20 and 24 are rejected as being dependent upon and including all of the limitations of claim 13.
Claim Rejections - 35 USC § 112(a)
14. 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.
15. Claims 1-8, 12-21 and 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating diabetes comprising administering a therapeutically effective amount of methysergide or 1-(2-hydroxy-3-(naphthalen-2-yloxy)propyl)-4-(quinolin-3-yl)piperidin-4-ol to a subject in need thereof, does not reasonably provide enablement for a method of treating diabetes comprising administering a therapeutically effective amount of any HTR1F antagonist, as claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
16. Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.”
17. In the instant case, the claimed invention pertains to a method of treating diabetes comprising administering a therapeutically effective amount of any HTR1F antagonist to the subject.
18. The State of the Prior Art and the Relative Skill of those in the Art, and The Level of Predictability in the Art: : As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed.”
19. As discussed above, the instantly claimed invention pertains to a method of treating diabetes in a subject in need thereof comprising administering “a therapeutically effective amount of a serotonin receptor 1F (HTR1F) antagonist to a subject in need thereof.” Cabello-Olmo et al. teach that type 1 diabetes is a complex, inflammatory, autoimmune disease that can present challenges to treat: “Type 1 diabetes mellitus (T1D) is an autoimmune illness that affects millions of patients worldwide. The main characteristic of this disease is the destruction of pancreatic insulin-producing beta cells that occurs due to the aberrant activation of different immune effector cells. Currently, T1D is treated by lifelong administration of novel versions of insulin that have been developed recently; however, new approaches that could address the underlying mechanisms responsible for beta cell destruction have been extensively investigated. The strategies based on immunotherapies have recently been incorporated into a panel of existing treatments for T1D, in order to block T-cell responses against beta cell antigens that are very common during the onset and development of T1D. However, a complete preservation of beta cell mass as well as insulin independency is still elusive. As a result, there is no existing T1D targeted immunotherapy able to replace standard insulin administration.” (See abstract). Cabello-Olmo et al. go on to teach that “the transplantation of pancreas or pancreatic islets (Edmonton Protocol) [7] have had limited success due to the insufficient number of donors and the reactivation of the autoimmunity status despite immunosuppression protocols. Additionally, pancreas transplants have been demonstrated to be only partially successful [8].” (page 2, first two paragraphs).
20. Regarding the state of the art of serotonin receptor 1F antagonists, the recited “HTR1F antagonist” embraces any compound that blocks the activation of HTR1F receptors including a compound of instant Formula (I); and any compound known to antagonize other serotonin receptors and also having an inhibitory effect on HTR1F including methysergide, cyanopindool, ergoline alkaloids (e.g., metergoline, methylergonovine), tricyclic thiepines/ thiepanes (e.g. methiothepin), 1-napthylpiperazine, indole alkaloids (e.g., yohimbine), phenylindoles (e.g. sertindole); in addition to any antibody that binds to HTRIF, wherein the term "antibody" refers to a protein with an immunoglobulin fold that specifically binds to an antigen via its variable regions, including intact polyclonal antibodies, intact monoclonal antibodies, single chain antibodies, multi specific antibodies such as bispecific antibodies, nonspecific antibodies, monovalent antibodies, chimeric antibodies, humanized antibodies, and human antibodies; and any nucleic acid that inhibits the expression of HTRIF, for example an siRNA or shRNA that mediates RNAi by targeting and inhibiting the expression of HTRIF.
21. Accordingly, at the time the invention was made, the relative skill of those in the art tasked with identifying compounds exerting an activity of interest would have been high, as the ordinarily skilled artisan would have had, at minimum, a Ph.D.
22. The Amount of Direction Provided by the Inventor / Existence of Working Examples: The amount of direction provided by the Applicant is considered to be determined by the Specification and the working examples. In the instant case, the Specification discloses just two Examples: methysergide (Example 5) OR 1-(2-hydroxy-3-(naphthalen-2-yloxy)propyl)-4-(quinolin-3-yl)piperidin-4-ol (Example 6) (Specification, pages 29-31).
Thus, support cannot be found for the use of any HTR1F antagonist, as instantly claimed.
23. Scope or Breadth of the Claims: As stated in MPEP 2164.01(c), “[w]hen a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation.” For purposes of enablement, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate in scope with the protection sought by the claims. As noted by the court in In re Fisher, 427 F.2d 833 (CCPA 1970), the scope of enablement must bear a “reasonable correlation” to the scope of the claims. See also Ak Steel Corp. v. Sollac, 344 F.3d 1234 (Fed. Cir. 2003) and In re Moore, 439 F.2d 1232 (CCPA 1971). As stated in MPEP 2164.08, resolution of this concern requires two stages of inquiry: “[t]he first is to determine how broad the claim is with respect to the disclosure. The entire claim must be considered. The second inquiry is to determine if one skilled in the art is enabled to make and use the entire scope of the claim without undue experimentation.”
24. As to the first inquiry, as discussed above, the claims are drawn to a method of treating diabetes in a subject in need thereof comprising “administering a therapeutically effective amount of a serotonin receptor 1F (HTR1F) antagonist to a subject in need thereof.” Considering that the genus of HTR1F antagonists encompasses hundreds of millions of compounds, it is evident that the claims are broad. Yet, as discussed above, the instant Specification discloses only two Examples of HTR1F antagonists (methysergide and 1-(2-hydroxy-3-(naphthalen-2-yloxy)propyl)-4-(quinolin-3-yl)piperidin-4-ol), as recited by the claims.
25. In the Specification at page 14, Applicant describes that the HTRIF antagonist may be any compound which is known to antagonize other serotonin receptors and may also exhibit an inhibitory effect on HTR1F, including for example methysergide ( known to antagonize HTR1A, HTR2A, HTR2B, and HTR2C), and including but not limited to, cyanopindool, ergoline alkaloids (e.g., metergoline, methylergonovine), tricyclic thiepines/ thiepanes (e.g. methiothepin), 1-napthylpiperazine, indole alkaloids (e.g., yohimbine), and phenylindoles (e.g. sertindole). Applicant sets forth that the HTRIF antagonist may be any antibody that binds to HTRIF, wherein the term "antibody" refers to a protein with an immunoglobulin fold that specifically binds to an antigen via its variable regions. The term encompasses intact polyclonal antibodies, intact monoclonal antibodies, single chain antibodies, multi specific antibodies such as bispecific antibodies, nonspecific antibodies, monovalent antibodies, chimeric antibodies, humanized antibodies, and human antibodies (pages 14-15). Applicant sets forth that the HTR1F antagonist may be any nucleic acid that inhibits the expression of HTRIF, for example an siRNA or shRNA that mediates RNAi by targeting and inhibiting the expression of HTRIF. Other useful nucleic acid-based inhibitors include microRNAs and antisense oligonucleotides (pages 15-16).
26. As such, it is evident that the genus of compounds embraced by “HTR1F antagonist” has substantial variance. Indeed, the genus is virtually without limit, embracing hundreds of millions of potential compounds bearing no structural resemblance to one another what-so-ever, for example, methiothepin, methysergide or a derivative thereof, and compound according to recited Formula (I) or a pharmaceutically acceptable salt thereof, and any antibody that binds HTR1F, and/or any nucleic acid that inhibits the expression of HTR1F. Yet, the instant Specification discloses only two Examples of HTR1F antagonists (methysergide and 1-(2-hydroxy-3-(naphthalen-2-yloxy)propyl)-4-(quinolin-3-yl)piperidin-4-ol) and demonstrates the activity of the two disclosed HTR1F antagonist compounds in Examples 5 and 6, Specification pages 29-31.
As such, the claim is extremely broad with respect to the disclosure. The second inquiry is discussed in detail below.
27. Amount of Experimentation Necessary: In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the invention as claimed. As discussed above, the claims are drawn to a method of providing opioid overdose rescue to a patient in need thereof comprising concurrently administering a therapeutically effective amount of any opioid antagonist and any antipsychotic agent, which embrace a broad genus of each agent. Given the unpredictability of administering antipsychotic agents in particular, as evidenced by Lader it is highly unpredictable whether any combination of an opioid antagonist and an antipsychotic agent would, in fact, be usable. That is, the only way one skilled in the art is enabled to use the entire scope of the claim based on the instant disclosure entails undue experimentation.
As such, claims 1-8, 12-21 and 24 are rejected.
Claim Rejections - 35 USC § 103
28. 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.
29. 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.
30. Claims 1-8, 12-20 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Harp, Joyce, U.S. 2020/0405728 A1 (cited on Applicant’s IDS of September 18, 2023), and further in view of Bruni et al., Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy 2014.
Claim 1 is drawn to a method of treating diabetes (more specifically type 1 diabetes or type 2 diabetes (claim 2)), the method comprising administering a therapeutically effective amount of a serotonin 1F (HTR1F) antagonist to a subject in need thereof, (more specifically the HTR1F antagonist
1-(2-hydroxy-3-(naphthalen-2-yloxy)propyl)-4-(quinolin-3-yl)piperidin-4-ol) (claims 5-8)),
wherein the HTR1F is administered in conjunction with pancreatic islet transplantation, wherein said pancreatic islets are treated with the HTR1F antagonist before transplantation to said subject (claims 3 and 4),
In view of a broadest reasonable interpretation, the recitation of “in conjunction with pancreatic islet transplantation” is construed to mean:
The method of claim 1, wherein the subject in need thereof is additionally treated with a pancreatic islet cell transplantation, wherein the islet cells are treated with said HTR1F antagonist prior to transplantation.
Claim 12 is drawn to claim 1, wherein the HTR1F antagonist is administered as a pharmaceutical composition comprising the HTR1F and a pharmaceutically acceptable excipient.
Claim 13 is drawn to a method for transplanting pancreatic islets to a subject comprising delivering pancreatic islets to the subject in conjunction with an HTR1F antagonist, (more specifically the HTR1F antagonist
1-(2-hydroxy-3-(naphthalen-2-yloxy)propyl)-4-(quinolin-3-yl)piperidin-4-ol) (claims 17-20)), and
wherein the subject has diabetes (claim 24).
In view of a broadest reasonable interpretation, the recitation of “in conjunction with an HTR1F antagonist” is construed to mean:
A method of treating a subject comprising transplanting pancreatic islet cells to said subject, wherein the islet cells are treated with an HTR1F antagonist prior to transplantation.
Claim 16 is drawn to claim 13, wherein the pancreatic islets are treated with the HTR1F antagonist before delivering the pancreatic islets to the subject.
31. Harp et al. disclose and recite the treatment of diabetes, comprising administering a serotonin receptor antagonist, specifically a 5HT1F antagonist to a diabetic patient, i.e., “[a] method for restoring normal glucagon secretion comprising administering to a patient known to have Type 1 diabetes or Type 2 diabetes a therapeutically effective amount of at least one antagonist selected from the group consisting of a histamine 1 receptor antagonist, a histamine 3 receptor antagonist, and a combination histamine 1/3 receptor antagonist, in response to insulin induced hypoglycemia in the patient,” “wherein the administration of the therapeutically effective amount of at least one antagonist prevents or treats hypoglycemia in patients in need of therapy for hypoglycemia, or in a patient known to have Type 1 diabetes [or] Type 2 diabetes,” “wherein the serotonin receptor antagonist is a 5HT1F antagonist” [emphasis added] (see Claims 1-3 and 6).
32. Harp et al. teach a pharmaceutical composition, i.e., “[i]n some embodiments, the therapeutic agents disclosed herein are administered in a pharmaceutical composition that includes a pharmaceutically acceptable carrier, adjuvant, excipient, or vehicle,” (paragraph [0076]).
33. Harp et al. are silent to the treatment of diabetes comprising administering the recited HTR1F antagonist 1-(2-hydroxy-3-(naphthalen-2-yloxy)propyl)-4-(quinolin-3-yl)piperidin-4-ol).
34. Yet, Koch et al. teach the 5HT1F antagonistic activity of substituted piperidines according to Formula I (column 1), and specifically naming Applicant’s instantly recited 5-HT1F antagonist in a subgenus of preferred compounds: 1-((2R)-hydroxy-3-(naphth-2-yloxy)prop-1-yl)-4-hydroxy-4-(isoquinolin-4-yl) piperidine (see column 5, lines 25-26).
35. In this case, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter.1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that "the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is described' as that term is used in 35 U.S.C. § 102(a), in that publication."). Id. at 1718. See also In re Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982).
36. As such, one of skill in the art would have reasonably considered selecting the 5-HT1F antagonist 1-((2R)-hydroxy-3-(naphth-2-yloxy)prop-1-yl)-4-hydroxy-4-(isoquinolin-4-yl) piperidine for treating a subject suffering from diabetes and in need of treatment with a 5-HT1F antagonist, as guided by Harp et al, and would have had a reasonable expectation of success.
37. And, one of skill in the art would be motivated to modify Harp et al. by employing the instantly recited 5-HT1F (HTR1F) antagonist in the treatment of diabetes, with a reasonable expectation of success. And, as noted by the court in In re Font, 675 F.2d 297 (CCPA 1982), an express suggestion to substitute one equivalent component (i.e., an equivalent 5-HT1F antagonist) for another is not necessary to render such substitution obvious. In the instant case, (1) the prior art element of Harp et al. teaches the function specified in the claim, i.e. treating type 1 or type 2 diabetes comprising administering an HTR1F antagonist; (2) the claimed component (i.e. 1-((2R)-hydroxy-3-(naphth-2-yloxy)prop-1-yl)-4-hydroxy-4-(isoquinolin-4-yl) piperidine) and its function (antagonizing serotonin receptor 1F) was known in the art as taught by Koch et al.; (3) a person of ordinary skill in the art would have recognized the interchangeability of the elements; and (4) the results would have been predictable, successful treatment of diabetes in a subject in need thereof.
38. Harp et al. additionally teach wherein the diabetic patient has undergone islet cell transplantation (paragraph [0082]), and disclose a method of treating donor pancreatic islet cells with an antagonist in Example 2 (paragraphs [0110]-[0113]), but do not teach a method of transplanting pancreatic islets in a subject in need thereof.
39. However, Bruni et al. teach that pancreatic islet transplantation is a well-established therapeutic treatment for a subset of patients with complicated type I diabetes mellitus, establishing success with insulin dependent rates up to 5 years post transplant with minimal complications (see abstract).
40. As such, one of skill in the art would have been motivated to treat diabetes in a subject in need thereof comprising administering the HTR1F antagonist 1-((2R)-hydroxy-3-(naphth-2-yloxy)prop-1-yl)-4-hydroxy-4-(isoquinolin-4-yl) piperidine in combination with transplantation of pancreatic islets in said subject, wherein the islet cells are treated with said HTR1F antagonist prior to transplantation, in order to achieve an additive effect in the treatment of diabetes in said subject. MPEP 2144 teaches that the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.
41. And, as stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976); see also: Merck v. Biocraft (874 F.2d 804, 807 (Fed. Cir. 1989), indicating that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands; Sundance, Inc. v. DeMonte Fabricated, Ltd., 550 F.3d 1356 (Fed. Cir. 2008): a claimed invention is obvious is it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they had been combined.
As such, claims 1-8, 12, 13, 16-20 and 24 are prima facie obvious.
Claim 14 is drawn to claim 13, wherein the pancreatic islets are delivered to the liver of the subject. Claim 15 is drawn to claim 13, wherein the pancreatic islets are implanted under a kidney capsule in the subject.
42. Bruni et al. additionally teach that alternative islet transplantation sites may be advantageous, including liver and below the kidney capsule: “Numerous sites have been proposed and tested, both experimentally and in some cases clinically, including the liver, kidney subcapsule, spleen, pancreas, omentum, gastrointestinal wall, immune privileged sites, and subcutaneous spaces,” (page 217, right column, second paragraph).
43. Thus, one of skill in the art would reasonably consider an alternative islet transplantation site selected from liver or under a kidney capsule, when practicing the method of Bruni et al. and transplanting islet cells pretreated with an HTR1F antagonist into a subject suffering from diabetes.
As such, claims 14 and 15 are prima facie obvious.
Conclusion
44. Claims 1-24 are present in the application. Claims 9-11 and 21-23 are presently withdrawn from consideration as directed to nonelected subject matter. Claims 1-8, 12-20 and 24 are rejected. No claim is presently allowed.
45. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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/JANET L COPPINS/Examiner, Art Unit 1628
/Rayna Rodriguez/Primary Examiner, Art Unit 1628