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 .
DETAILED ACTION
Claims 1-14 are pending in the application. Claims 1-14 are rejected. Claims 1-14 are objected to.
Priority
This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/GB2022/051955, filed on July 26, 2022, which claims priority to U.K. Application No. GB2110728.9, filed on July 26, 2021.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. § 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on January 24, 2024 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Specification
The amendment filed on January 24, 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the sentence “The entire teachings of the above applications are incorporated herein by reference.”
MPEP 211.02 and MPEP 201.06(c)(IV) state the following in regard to “Incorporation by Reference” and PCT Rule 20.6, Rule 20.7 and Rule 4.18 are directed specifically to International applications:
MPEP 211.02, in-part
For applications filed on or after September 21, 2004, a claim under 35 U.S.C. 119(e) or 120 and 37 CFR 1.78 for benefit of a prior-filed provisional application, nonprovisional application, international application designating the United States, or international design application designating the United States that was present on the filing date of the continuation or divisional application, or the nonprovisional application claiming benefit of a prior-filed provisional application, is considered an incorporation by reference of the prior-filed application as to inadvertently omitted material, subject to the conditions and requirements of 37 CFR 1.57(b). The purpose of 37 CFR 1.57(b) is to provide a safeguard for applicants when all or a portion of the specification and/or drawing(s) is (are) inadvertently omitted from an application. See MPEP § 201.06 and 217. However, applicants are encouraged to provide in the specification an explicit incorporation by reference statement to the prior-filed application(s) for which benefit is claimed under 35 U.S.C. 119(e) or 120 if applicants do not wish the incorporation by reference to be limited to inadvertently omitted material pursuant to 37 CFR 1.57(b). See 37 CFR 1.57(c). See also MPEP §§ 217 and MPEP § 608.01(p).
When a benefit claim is submitted after the filing of an application, and the later-filed application as filed did not incorporate the prior-filed application by reference, applicant cannot add an incorporation by reference statement of the prior application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a) ). See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980). See also 37 CFR 1.57(b).
MPEP 201.06(c)(IV), in-part
201.06(c) 37 CFR 1.53(b) and 37 CFR 1.63(d) Divisional-Continuation Procedure [R-08.2017]
IV. INCORPORATION BY REFERENCE
An applicant may incorporate by reference the prior application by including, in the continuing application-as-filed, an explicit statement that such specifically enumerated prior application or applications are “hereby incorporated by reference.” The statement must appear in the specification. See 37 CFR 1.57(c) and MPEP § 608.01(p). The inclusion of this incorporation by reference statement will permit an applicant to amend the continuing application to include subject matter from the prior application(s), without the need for a petition provided the continuing application is entitled to a filing date notwithstanding the incorporation by reference. For applications filed prior to September 21, 2004, the incorporation by reference statement may appear in the transmittal letter or in the specification. Note that for applications filed prior to September 21, 2004, if applicants used a former version of the transmittal letter form provided by the USPTO, the incorporation by reference statement could only be relied upon to add inadvertently omitted material to the continuation or divisional application.
An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a) ). If an incorporation by reference statement is included in an amendment to the specification to add a benefit claim under 35 U.S.C. 120 after the filing date of the application, the amendment would not be proper. When a benefit claim under 35 U.S.C. 120 is submitted after the filing of an application, the reference to the prior application cannot include an incorporation by reference statement of the prior application. See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980).
20.6 Confirmation of Incorporation by Reference of Elements and Parts
(a) The applicant may submit to the receiving Office, within the applicable time limit under Rule 20.7, a written notice confirming that an element or part is incorporated by reference in the international application under Rule 4.18, accompanied by:
(i) a sheet or sheets embodying the entire element as contained in the earlier application or embodying the part concerned;
(ii) where the applicant has not already complied with Rule 17.1(a), (b) or (b-bis) in relation to the priority document, a copy of the earlier application as filed;
(iii) where the earlier application is not in the language in which the international application is filed, a translation of the earlier application into that language or, where a translation of the international application is required under Rule 12.3(a) or 12.4(a), a translation of the earlier application into both the language in which the international application is filed and the language of that translation; and
(iv) in the case of a part of the description, claims or drawings, an indication as to where that part is contained in the earlier application and, where applicable, in any translation referred to in item (iii).
(b) Where the receiving Office finds that the requirements of Rule 4.18 and paragraph (a) have been complied with and that the element or part referred to in paragraph (a) is completely contained in the earlier application concerned, that element or part shall be considered to have been contained in the purported international application on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office.
(c) Where the receiving Office finds that a requirement under Rule 4.18 or paragraph (a) has not been complied with or that the element or part referred to in paragraph (a) is not completely contained in the earlier application concerned, the receiving Office shall proceed as provided for in Rule 20.3(b)(i), 20.5(b) or 20.5(c), as the case may be.
20.7 Time Limit
(a) The applicable time limit referred to in Rules 20.3(a) and (b), 20.4, 20.5(a), (b) and (c), and 20.6(a) shall be:
(i) where an invitation under Rule 20.3(a) or 20.5(a), as applicable, was sent to the applicant, two months from the date of the invitation;
(ii) where no such invitation was sent to the applicant, two months from the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office.
(b) Where neither a correction under Article 11(2) nor a notice under Rule 20.6(a) confirming the incorporation by reference of an element referred to in Article 11(1)(iii)(d) or (e) is received by the receiving Office prior to the expiration of the applicable time limit under paragraph (a), any such correction or notice received by that Office after the expiration of that time limit but before it sends a notification to the applicant under Rule 20.4(i) shall be considered to have been received within that time limit.
4.18 Statement of Incorporation by Reference
Where the international application, on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office, claims the priority of an earlier application, the request may contain a statement that, where an element of the international application referred to in Article 11(1)(iii)(d) or (e) or a part of the description, claims or drawings referred to in Rule 20.5(a) is not otherwise contained in the international application but is completely contained in the earlier application, that element or part is, subject to confirmation under Rule 20.6, incorporated by reference in the international application for the purposes of Rule 20.6. Such a statement, if not contained in the request on that date, may be added to the request if, and only if, it was otherwise contained in, or submitted with, the international application on that date.
The instant application is a 371 application which has an International filing date of July 26, 2022.
Specifically, PCT/GB2022/051955 was filed without an “incorporation by reference” statement to the earlier application filed in the U.K. Then, Applicant filed a 371 of the PCT and attempted to amend the specification to include the “incorporation by reference” statement via a preliminary amendment filed January 24, 2024, which is after the instant application's International filing date of July 26, 2022. This is considered new matter. MPEP 201.06(c): “An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)).”
Applicant is required to cancel the new matter in the reply to this Office Action.
This objection to the specification can be overcome by deleting the entirety of “The entire teachings of the above applications are incorporated herein by reference” from the instant specification.
Claim Objections
Claims 4-14 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. MPEP § 608.01(n) states
A multiple dependent claim may not serve as a basis for any other multiple dependent claim, either directly or indirectly. These limitations help to avoid undue confusion in determining how many prior claims are actually referred to in a multiple dependent claim.
For the purposes of examination, claims 4-14 are being interpreted as being dependent on claim 1.
In addition, claims 1-14 are objected to because of the following informalities:
Claim 1 should be amended to include the word -or- before the last recited alternative (i.e.,
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Claim 1 should be amended to include the word -or- before the last recited alternative (i.e.,
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) for variable “R3” for proper Markush language. See page 105.
Claim 1 should be amended to include hyphens before and/or after each of
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and
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for sake of consistency. See variable “L2” as defined on page 106.
Claim 1 should be amended to include the word -or- after “phenyl,” for sake of clarity and proper Markush language. See “Ring C” definition as recited on page 107.
Claim 1 should be amended to include the word -or- before the last recited alternative (i.e.,
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) for variable “R4” for proper Markush language. See page 107.
Claim 1 should be amended to replace the word “fluoro” with -fluorine- for sake of clarity. See variable “L” definition as recited on page 107.
Claim 1 should be amended to include the word -or- before “-C(O)-” as recited for variable “X” for proper Markush language. See page 107.
Claim 1 should be amended to include a hyphen after
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for sake of consistency. See variable “L4” definition as recited on page 109.
Claim 1 should be amended to cancel the word “or” found at the end of the third line of the definition of variable “L4” as recited on page 109.
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Claim 1 should be amended to include the word -or- before “(iv) a group of the formula V or VI” on page 108 for sake of proper Markush language.
Claim 2 should be amended to replace “A compound according to claim 1” with -The compound according to claim 1- for sake of clarity.
Claim 2 should be amended to include the word -or- before the last recited alternative (i.e.,
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) for variable “R2” for proper Markush language. See page 110.
Claim 2 should be amended to replace the word “fluoro” with -fluorine- for sake of clarity. See variable “L” definition as recited on page 112.
Claim 2 should be amended to include the word -or- after “phenyl,” for sake of clarity and proper Markush language. See “Ring C” definition as recited on page 114.
Claim 2 should be amended to include the word -or- before the last recited alternative (i.e.,
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) for variable “R4” for proper Markush language. See page 114. Applicant should also cancel the comma following this last recited alternative.
Claim 2 should be amended to include the word -or- before “-C(O)-” as recited for variable “X” for sake of proper Markush language. See page 114.
Claim 2 should be amended to cancel the comma following the last recited alternative for variable “R4.” See page 114.
Claim 2 should be amended to include the word -or- before “(iv) a group of the formula V or VI” on page 115 for proper Markush language.
Claim 3 should be amended to replace “A compound according to claim 1 or 2” with -The compound according to claim 1 or 2- for sake of clarity.
Claim 3 should be amended to cancel the comma following the last recited alternative for variable “L1.” See page 118.
Claim 3 should be amended to replace the word “fluoro” with -fluorine- for sake of clarity. See variable “L” definition as recited on page 119.
Claim 3 should be amended to include the word -or- after “phenyl,” for sake of clarity and proper Markush language. See “Ring C” definition as recited on page 120.
Claim 3 should be amended to include the word -or- before “-C(O)-” as recited for variable “X” for proper Markush language. See page 120.
Claim 3 should be amended to cancel the comma and dash found immediately after
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as recited for variable “L4” on page 122.
Claim 3 should be amended to include the word -or- before “(iv) a group of the formula V or VI” on page 121 for proper Markush language.
Claim 4 should be amended to include the word -or- before the last recited alternative (i.e.,
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) for variable “R2” on page 123. Applicant should also cancel the comma appearing immediately after this last recited alternative.
Claim 4 should be amended to cancel the semicolon appearing after the definition of variable “Y2” on page 125.
Claim 4 should be amended to replace the word “fluoro” with -fluorine- for sake of clarity. See variable “L” definition as recited on page 125.
Claim 4 should be amended to include the word -or- after “phenyl,” for sake of clarity and proper Markush language. See “Ring C” definition as recited on page 126.
Claim 4 should be amended to include the word -or- before the last recited alternative (i.e.,
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) for variable “R4” on page 126. Applicant should also cancel the comma appearing immediately after this last recited alternative.
Claim 4 should be amended to include the word -or- before “-C(O)-” as recited for variable “X” for sake of proper Markush language. See page 126.
Claim 4 should be amended to cancel the comma and dash found immediately after
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as recited for variable “L4” on page 128.
Claim 4 should be amended to include the word -or- before “(iv) a group of the formula V or VI” on page 127 for sake of proper Markush language.
Claim 5 should be amended to include the word -or- before the last recited alternative (i.e.,
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) for variable “R2” on page 129. Applicant should also cancel the comma appearing after this last recited alternative for sake of clarity.
Claim 5 should be amended to cancel the additional semicolon appearing immediately after “-C(O)-” as recited in the definition for variable “L1” on page 129.
Claim 5 should be amended to include the word -or- before the last recited alternative (i.e.,
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) for variable “R4” on page 131. Applicant should also cancel the comma appearing after this last recited alternative for sake of clarity.
Claim 5 should be amended to replace the word “fluoro” with -fluorine- for sake of clarity. See variable “L” definition as recited on page 132.
Claim 5 should be amended to cancel the additional semicolon appearing immediately after “-C(O)-” as recited in the definition for variable “X” on page 132.
Claim 5 should be amended to include the word -or- before “(iv) a group of the formula V or VI” on page 132 for proper Markush language.
Claim 5 should be amended to replace the word “or” appearing before “-C(O)-” as recited for variable “L4” on page 133 with a comma. In addition, Applicant should cancel the comma and dash appearing after
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in the next line.
Claim 6 should be amended to cancel the comma present after “-OR2a” as recited for variable “R2” on page 134.
Claim 6 should be amended to cancel the additional semicolon appearing immediately after “-C(O)-” as recited in the definition for variable “L1” on page 134.
Claim 6 should be amended to replace the word “fluoro” with -fluorine- for sake of clarity. See variable “L” definition as recited on page 135.
Claim 6 should be amended to replace “phenylor” with -phenyl or- in the definition of variable “Y2” on page 135.
Claim 6 should be amended to replace the word “fluoro” with -fluorine- for sake of clarity. See variable “L” definition as recited on page 136.
Claim 6 should be amended to cancel the additional semicolon appearing immediately after “-C(O)-” as recited in the definition for variable “X” on page 136.
Claim 6 should be amended to include the word -or- before “(iv) a group of the formula Va or VIa” on page 136 for proper Markush language.
Claim 7 should be amended to cancel the extra dash appearing before
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in variable “L4” on page 137.
Claim 7 should be amended to cancel both the comma and semicolon found immediately after “-OR2a” as recited for variable “R2” on page 138.
Claim 7 should be amended to include the word -or- before “(iv) a group of the formula Va or VIa” on page 140 for proper Markush language.
Claim 8 should be amended to cancel both the comma and semicolon found immediately after “-OR2a” as recited for variable “R2” on page 142.
Claim 8 should be amended to include the word -or- before “(iv) a group of the formula Vb, Vc, VIb or VIc” on page 144 for proper Markush language.
Claim 9 should be amended to include the word or before the last recited compound (reproduced below) on page 146.
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Claim 10 should be amended to replace “comprising a compound according to” with -comprising the compound according to- for sake of clarity.
Claim 12 should be amended to replace “inflammaroty skin conditions” with -inflammatory skin condition- on page 147.
Claims 4-9 and 11-14 should be amended to replace “A compound according to” with -The compound according to- for sake of clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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 11 and 12 are rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA ), first paragraph.
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The specification, while being enabling for the therapy and treatment of the above diseases, stated in paragraph [00176], does not reasonably provide enablement for “use in therapy” and “use in the treatment” of...cardiovascular disease, inflammatory bowel condition, cancer, liver disease, inflammatory skin conditions, etc. which could reasonably be interpreted as any and all therapies and any and all cardiovascular diseases, inflammatory bowel conditions, cancers, etc., respectively. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with this claim.
As a general rule, enablement must be commensurate in scope with the claim language. The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). See MPEP § 2164.08. That some experimentation may be required is not fatal; the issue is whether the amount of experimentation required is “undue.” In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
The above factors, regarding the present invention, are summarized as follows:
Breadth of the Claim – The breadth of the claims is drawn to the compound of formula I for use in either therapy or the treatment of various and broad disease types as recited in claim 12. Note that the specific disease subtypes recited in claim 12 are not considered further limiting due to exemplary language as indicated below in the rejection under 35 U.S.C. 112(b). Accordingly, the claims are drawn towards a countless number of therapies and treatment of a wide variety of diseases (e.g., cardiovascular disease, inflammatory bowel condition, cancer, etc.).
Nature of the Invention – The nature of the invention is “to provide compounds that suppress the proinflammatory effects of monomeric extracellular nicotinamide phosphoribosyl transferase (eNAMPT).” See e.g., page 2 of the instant specification.
State of the Prior Art and Predictability in the Art – Even in view of the seemingly high level of skill in the art, there is no absolute predictability when determining the physiological effects of a compound of formula I against any and all cardiovascular diseases, inflammatory bowel conditions, cancers, inflammatory skin conditions, etc. In addition, there is no absolute predictability when determining the effectiveness of a compound of formula I in any and all therapies. It is well established that “the scope of enablement [] varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). Consider, for instance, the broad number of cancers which fall under the category of “cancer” as recited in claim 12. Lipinski et al. (Trends in Cancer, 2016, 49-63) teach “[g]enomic aberrations differ between cancers of the same histological type, to the extent that no two tumors are thought to show an identical somatic genetic aberration profile.” See e.g., page 49. Therefore, a skilled artisan would reasonably expect the efficacy of treatment methods to vary when considering the diverse causes and symptoms associated with any and all cancers. In addition, a skilled artisan would have no reasonable expectation of success that the instantly claimed compound of formula I would be effective when used in any therapy. For instance, the term “therapy” encompasses an extremely large number of therapy types- most of which are completely unrelated to the instant invention (e.g., smoking cessation therapy, mental health therapy, physical therapy, etc.).
Relative Skill of Those in the Art – The artisan making and using applicant’s pharmaceutical compound would be a synthetic chemist and/or a health practitioner, possessing a commensurate degree level and/or skill in the art, as well as several years of professional experience. The level of skill in the art is high; however, due to the unpredictability in the pharmaceutical art and the wide scope of cancers, it is difficult to assess the potential pharmacological activity of a compound of formula I for use in any and all therapies and for use in treating any and all of the disease types recited in claim 12.
Amount of Direction/Guidance Provided and Existence/Absence of Working Examples – The specification provides in vitro data regarding the instantly claimed compound of formula I and NAMPT metabolic inhibition. See e.g., pages 101 and 102. The disclosure, however, does not provide support for the full scope of claims 11 and 12, which encompasses a compound of formula I for use in any and all therapies and for use in treating any and all of the disease types recited in claim 12Quantity of Experimentation Necessary – The quantity of experimentation needed to use the invention based on the content of the disclosure is undue. One of skill in the art would need to determine which specific disease/therapy not embraced by the instant disclosure would benefit from the pharmacological activities of a compound of formula I by administering said compound to a patient. Using the full scope of the instant claim is made further burdensome when one considers that even human testing “limited to one compound and two types of cancer” was not “commensurate with the broad scope of utility asserted and claimed.” In re Buting, 57 CCPA 777, 418 F.2d 540, 163 USPQ 689. The claimed invention would require a person having ordinary skill to invest an indefinite amount of experimentation clearly beyond what can be considered as routine.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976). In view of the Wands factors and In re Fisher (CCPA 1970) discussed above, a person of skill in the art would have to engage in undue experimentation to test which disease treatment/therapy would derive benefit from a compound of formula I, with no assurance of success. It is suggested Applicant i) limit the intended use statement of claim 11 to a specific therapy type as supported by the original disclosure; and ii) limit the intended use statement of claim 12 to diseases enabled by the instant specification e.g., incorporate disease limitations of instant claim 13 into claim 12 without using exemplary language (i.e., “(e.g....)”).
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION — The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 are rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. § 112, the applicant), regards as the invention.
Claim 1 recites multiple instances of variable “Ry1a” within the list of alternatives recited for variable “Y1” (reproduced below) on page 104.
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However, claim 1 does not define variable “Ry1a” and is, therefore, rejected as indefinite. In addition, claim 1 provides a definition for variable “Ry1” (reproduced below) although there is a lack of antecedent basis for variable “Ry1” in the claim.
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As both these issues of indefiniteness appear to stem from a single typographical error, it is suggested Applicant amend claim 1 to replace the instance of “Ry1” with “Ry1a” to overcome these issues of indefiniteness.
Claim 1 recites multiple instances of variable “Ry4a” within the list of alternatives recited for variable “Y4” (reproduced below) on pages 109 and 110.
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However, claim 1 does not define variable “Ry4a” and is, therefore, rejected as indefinite. In addition, claim 1 provides a definition for variable “Ry4” (reproduced below) although there is a lack of antecedent basis for variable “Ry4” in the claim.
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As both these issues of indefiniteness appear to stem from a single typographical error, it is suggested Applicant amend claim 1 to replace the instance of “Ry4” with “Ry4a” to overcome these issues of indefiniteness. Claims 1-4 each recite the following proviso statements with respect to formula V or VI and are rejected as indefinite.
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In each claim, it is unclear how variable “A40” can be either N or CR2 when hitherto “A40” was defined as follows:
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Claims 1-4 also recite the following proviso statement with respect to formula V or VI and are further rejected as indefinite.
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Similarly, in each claim it is unclear how variable “A51” can be N when hitherto “A51” was defined as follows:
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Claims 1-7 recite the limitation “wherein R2 is as defined above” and are rejected as indefinite (see pages 109, 115, 122, 128, 133, 137 and 141). In defining variable “R1” of the instantly claimed compound of formula I, Applicant organized within each claim the alternative definitions of “R1” into subcategories i.e., (i), (ii), (iii) and (iv). With the exception of the limitation “wherein R2 is as defined above” found in subcategory (iv), each subcategory is restricted to a specific, generic chemical formula(s) and variable definitions associated therewith. It is, therefore, unclear whether Applicant intended the limitation “wherein R2 is as defined above” as recited in subcategory (iv) to be in reference to a) variable “R2” as defined in subcategory (i), b) a separate “R2” definition which Applicant inadvertently omitted from somewhere above in subcategory (iv) or c) “R2” as defined in any of the above claims. It is suggested Applicant cancel this limitation and include a definition for “R2” within subcategory (iv) for each claim for sake of clarity and consistency. Dependent claims 8 and 10-14 do not correct this issue of indefiniteness and are likewise rejected.
Claim 2 recites multiple instances of variable “Ry1a” within the list of alternatives recited for variable “Y1” (reproduced below) on page 111.
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However, neither claim 2 nor parent claim 1 defines variable “Ry1a”; therefore, claim 2 is rejected as indefinite. In addition, claim 2 provides a definition for variable “Ry1” (reproduced below) although there is a lack of antecedent basis for variable “Ry1” in the claim (or in parent claim 1).
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As both these issues of indefiniteness appear to stem from a single typographical error, it is suggested Applicant amend claim 2 to replace the instance of “Ry1” with “Ry1a” to overcome these issues of indefiniteness.
Claim 2 recites multiple instances of variable “Ry4a” within the list of alternatives recited for variable “Y4” (reproduced below) on page 116.
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However, neither claim 2 nor parent claim 1 defines variable “Ry4a.” Therefore, claim 2 is rejected as indefinite. In addition, claim 2 provides a definition for variable “Ry4” (reproduced below) although there is a lack of antecedent basis for variable “Ry4” in the claim (or in parent claim 1).
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As both these issues of indefiniteness appear to stem from a single typographical error, it is suggested Applicant amend claim 2 to replace the instance of “Ry4” with “Ry4a” to overcome these issues of indefiniteness.
Claim 9 recites the expression “and, in particular” and is rejected as indefinite for two reasons. First, based on the expression “in particular”, it is unclear whether Applicant intended the recited chemical nomenclatures to be further limiting of the compound of formula I as recited in parent claim 1. Applicant should, therefore, remove exemplary language (i.e., “in particular”) from the claim. Secondly, based on the word “and” it is unclear whether claim 9 is drawn to a single species of a compound of formula I or a compound of formula I and another species selected from the list of recited compounds. Appropriate corrections are required (e.g., replace “and, in particular,” with -which is-).
Claims 12 and 13 recite “(e.g. ....)” and are rejected as indefinite because it is unclear whether the diseases recited within each “(e.g. ....)” is further limiting of the term preceding the parenthetical expression. It is suggested Applicant avoid exemplary language (i.e., the current usage of “(e.g. ....)”) and limit each claim to specific disease subtypes as appropriate.
Claim 14 recites “for example hepatic steatosis” and is rejected as indefinite. It is unclear whether Applicant intended “hepatic steatosis” to be further limiting of “non-alcoholic fatty liver disease.” It is suggested Applicant remove exemplary language (i.e., “for example”) and limit claim 14 to the “hepatic steatosis” which is a disease subtype of “non-alcoholic fatty liver disease.” Claim 14 also recites the expression “through inflammatory non-alcoholic steatohepatitis (NASH) to fibrosis or cirrhosis” and is further rejected as indefinite. It appears Applicant is attempting to encompass a wide range of undefined diseases through this vague expression; however, it is unclear what diseases are included in the recited indefinite range of diseases. Applicant should limit claim 14 to specific diseases to overcome the issue of indefiniteness.
Conclusion
No claims are allowed.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626