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 .
DETAIL ACTION
This office action is a response to a 371 application filed -----1/9/2023, which is a national stage application of PCT/EP2020/074892 filed 9/7/2020, which claims foreign priority to PCT/EP2020/069712 filed 7/13/2020.
As filed, claims 82-108 are pending; and claims 1-81 are cancelled.
Election/Restrictions
Regarding the election of species requirement, the Applicant elected the species of
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, with traverse. The abovementioned elected species can be found in pg. 73 of the instant specification. Because the Markush-type claims (i.e. claims 82, 94, 102, and 104) are determined to be free of prior art, the elections of species requirement is hereby withdrawn. Therefore, the Applicant’s traversal is now moot.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/17/2023 has been considered by the Examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities:
The amendment filed 1/9/2023 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: “each of which is incorporated by reference herein in its entirety”.
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).
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-07.2015]
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 9/7/2020. See a partial capture of the BIB sheet of the instant application below.
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The incorporation by reference statement is being added by way of a Preliminary Amendment filed 1/9/2023, which is after the instant application's International filing date of 9/7/2020. Therefore, the “incorporation by reference” statement being added to the instant specification by way of the Preliminary Amendment is deemed new matter.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 104-106 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
As stated in the MPEP § 2164.01(a): “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’.” In In re Wands (8 USPQ2d 1400 (Fed. Cir. 1988)), the Federal Circuit established that the following factors are to be considered when determining whether a disclosure meets the enablement requirement of the first paragraph of 35 U.S.C. § 112:
1) The nature of the invention – the instant claims are drawn to a method of treating a human or an animal suffering from a disease of the human or animal body via the compound of instant formula (IVa).
2) The state of the prior art – the pharmacological art requires the screening of potential drug candidates in vitro and in vivo to determine if the drug candidates exhibit the desired pharmacological activities.
In order to treat a disease: one would need to precisely identify what the disease is, identify what biological target is connected with the disease, demonstrate that the drug candidate in some way modulates the normal processes of the biological target, and demonstrate that a patient benefited from such modification without detrimental side effects. Typically, this process includes in vitro laboratory screening, preclinical in vivo screening, and three phases of clinical trials. Once this arduous process has been successfully completed by a drug candidate, subsequent drug candidates will benefit from the established proof of concept. The subsequent drug candidates must demonstrate a substantial correlation between their biological activity and that of the known drug candidate.
In the instant case, the method of treatment using the compounds of instant formula (IVa) is new and have not been disclosed in the art. More importantly, a substantial correlation between the compound of instant formula (IVa) and their biological target of energy metabolism or keto-body metabolism has not been established by the demonstration of any in vitro screening, preclinical in vivo screening, or three phases of clinical trial. Thus, generalizations in the method of treatment using the compound of instant formula (IVa) cannot be made.
3) The predictability or unpredictability of the art – the law recognizes the pharmaceutical art as an unpredictable art and requires each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18 24 (CCPA 1970). Accordingly, the more unpredictable an area is the more specific disclosure is necessary in order to satisfy the statute. Section 2164.02 of the MPEP provides:
"[C]orrelation” as used herein refers to the relationship between in vitro and in
vivo animal model assays and a disclosed or a claimed method of use . . . if the
art is such that a particular model is recognized as correlating to a specific
condition, then it should be accepted as correlating unless the examiner has
evidence that the model does not correlate.
In light of these remarks, the Examiner finds that one of ordinary skill in the art would agree with the court; that is, the pharmaceutical art is unpredictable. Thus, a substantial correlation is necessary for establishing the potential of new therapeutics.
4) The amount of direction or guidance presented – the instant specification briefly provides an explanation of the biological activity of keto bodies on pp. 1-5 and discusses the implication of regulating keto bodies in the treatment of strokes, dementia, etc.
The amount of guidance or direction to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. MPEP § 2164.03 (quoting In re Fisher, 427 F.2d 833, 839, 166 USPQ 18 24 (CCPA 1970)). As identified supra, the pharmaceutical art is recognized as unpredictable.
Thus, in order to support a claim for treating a disease related to keto-body metabolism, a minimum of in vitro screening data toward keto bodies is required because such a claim is not supported by the prior art or the instant specification.
5) The presence or absence of working examples - there are no working or prophetic examples in the specification that demonstrate that the compounds of instant formula (IVa) may regulate keto bodies, as instantly embraced.
Zero examples are not a “representative number of species” for an unpredictable art such as a chemical reaction. Ariad, 598 F.3d at 1354-55 (claiming that the inventor has an obligation to disclose examples when the art is unpredictable). In Ariad, the Federal Circuit also stated that “merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” In other words, a disclosure of particular species will earn significant evidentiary weight. There is no evidence provided in the instant specification or evidence provided in the information disclosure statement that is persuasive for implying that the prior art and knowledge of the artisans working in the art would be able to substitute for species in the specification.
6) The breadth of the claims – is incommensurate in scope with the disclosure because a fair reading of the specification fails to support a finding that the compounds of instant formula (IVa) may regulate keto bodies.
7) The quantity of experimentation necessary – generally speaking, the amount of experimentation to transform a molecule into medicine is vast and the success thereof is low. Recent statistics indicate that the attrition rates during drug development remain high. Schafer et al. Drug Discovery Today 2008, 13 (21/22), 913-916. The article makes clear that there are many steps necessary to promote a new molecular entity toward its clinical use, any one of which is cumbersome.
For instance, Schafer et al. discloses: "proof of concept trials have failed when the decision to enter clinical development was based on preclinical experiments using the wrong compound, the wrong experimental model, or the wrong endpoint.” It can be gleaned from this article that a plethora of experimentation is needed to identify the lead compound (i.e. one among many in a Markush-type claim), to establish which preclinical tests are predictive of clinical success, and to establish which diseases are the best to target for each lead compound.
There is generally a vast amount of experimentation to take a drug from bench to the clinic. See e.g., Horig et al. Journal of Translational Medicine 2004, 2(44) (“Successful drug development requires satisfying a matrix of domains from relevance to the disease and the drug-ability of the target through feasibility and convenience of drug delivery, demonstration of favorable benefit-risk profile in order to achieve a drug label that reflects physician and patent acceptance.") The Examiner finds that one of ordinary skill in the art would agree with the statements in these articles; that is, the amount of experimentation required to enable a pharmaceutical drug is extensive.
8) The level of skill in the art - the level of ordinary skill in the art may be found by inquiring into: (1) the type of problems encountered in the art; (2) prior art solutions to those problems; (3) the rapidity with which innovations are made; (4) the sophistication of the technology; and (5) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of those factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983).
Based on the typical education level of the active workers in the field of pharmaceuticals and/or medicine, as well as the high degree of sophistication required to solve problems encountered in the art, the Examiner finds that a person of ordinary skill in the art would have at least a college degree in a field related to medicine and/or the pharmaceutical art and at least four years of work experience, i.e. a masters or doctorate level scientist/clinician.
Conclusion – Claims 104-106 are rejected because the Examiner finds that the Wands factors suggest a conclusion that the skilled artisan would not be able to make and use the instant invention without undue experimentation (although the level of skill for an ordinary person in the art is high). That is, due to the breadth of the claims, the unpredictability of the art, the lack of guidance or direction from the disclosure, the lack of any working examples, and the amount of experimentation needed illustrate that a person having ordinary skill in the art would not be able to treat a disease of the human or animal body without undue experimentation, since correlation between the compound of instant formula (IVa) and the regulation of keto-body metabolism has not been established via any in vitro or in vivo screening assays.
Claim 85 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 85 recites the limitation, “naturally occuring carboxylic acids and their anhydrides and derivatives”, in reference to the instantly claimed polycarboxylic acid (II). Applicant has not described the claimed genus of “naturally occuring carboxylic acids and their anhydrides and derivatives” in a manner that would indicate they were in possession of the full scope of this genus, or even to describe what this genus is comprised of.
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to the MPEP §2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plain for obtaining the claimed chemical invention." Eli Lilly, 119 F.3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications under the 35 U.S.C. 112.1 "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5, 2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter aria, "functional characteristics when coupled with a known or disclosed correlation between function and structure..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)). Moreover, although Eli Lilly and Enzo were decided within the factual context of DNA sequences, this does not preclude extending the reasoning of those cases to chemical structures in general. Univ. of Rochester v. G.D. Searle & Co., 249 Supp. 2d 216, 225 (W.D.N.Y. 2003).
In the instant case, the claimed “naturally occuring carboxylic acids and their anhydrides and derivatives” encompass any carboxylic acid or anhydride, with a differing, limitless, and undefined variation quoted for the identical purpose. Applicants describe salt or ester (pg. 18, line 26) as examples of ““naturally occuring carboxylic acids and their anhydrides and derivatives””, in respect to instantly claimed polycarboxylic acid (II), which are not described adequately enough to allow one skilled in the art to ascertain that Applicant is in possession of the entire scope of that genus. Applicants have not described this genus in a manner that would allow one skilled in the art to immediately envisage the “naturally occuring carboxylic acids and their anhydrides and derivatives” contemplated for use. As such, the claim lacks adequate written description for the claimed “naturally occuring carboxylic acids and their anhydrides and derivatives” in respect to the instantly claimed polycarboxylic acid (II).
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 82-97, 99, and 101-108 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.
Regarding claim 82, the claim recites the phrases, “polycarboxylic acid (II)”, “polyglycerol (III)”, and “reaction product (IV)” without providing a structure. As a result, the claim does not stand alone and one must refer back to the specification to define the claimed invention to determine the metes and bounds of the claim and thus, the claim is rendered indefinite.
Regarding claim 82, the claim recites the following phrases,
“wherein the method is carried out as one of a one-step method and a method comprising several steps”; and
“wherein the method is carried out in the absence of any solvent”.
It is unclear to the Examiner which method (one step vs. several steps vs both) is carried out in the absence of any solvent. With such ambiguity, the metes and bounds of this claim is unclear, which rendered the claim indefinite.
Regarding claim 82, the claim recites the phrase, “wherein the resulting free polycarboxylic acid (II) is further reacted or after the reaction has taken place, is removed and recycled”. It is unclear to the Examiner whether “the reaction” in the phrase, “after the reaction has taken place” pertains to the main reaction among oxobutanol of instant formula (I), the polycarboxylic acid (II) and polyglycerol (III); or pertains to the further reaction in “wherein the resulting free polycarboxylic acid (II) is further reacted”. With such ambiguity, the metes and bounds of this claim is unclear, which rendered the claim indefinite.
Regarding claim 83, the claim recites the phrase ,”reaction intermediate (IV’)” without providing a structure. As a result, the claims do not stand alone and one must refer back to the specification to define the claimed invention to determine the metes and bounds of the claims and thus, the claims are rendered indefinite.
Regarding claim 92, the claim recites the phrase, ”reaction intermediate product (IV’)” without providing a structure. As a result, the claims do not stand alone and one must refer back to the specification to define the claimed invention to determine the metes and bounds of the claims and thus, the claims are rendered indefinite.
Regarding claims 83-93, the claims are directly or indirectly dependent of claim 82, and they failed to correct the indefiniteness issue of claim 82, which rendered these claims indefinite.
Regarding claims 94-96, 99, 102, 104, and 107, the claims recite the following phrase, “X represents a saturated or unsaturated organic radical comprising”.
Firstly, variable X recites the term "comprises." Forms of the term “comprise” are considered open-ended language and therefore include additional subject matter that is not described in the instant specification and is not particularly pointed out or distinctly claimed. The identity of the additional atoms or groups is unknown and how to determine the identity of the additional atoms or groups is not pointed out or distinctly claimed.
The term “compound” contradicts the open language "comprises." A "compound" is defined as a substance whose molecules consist of unlike elements and whose constituents cannot be separated by physical means. Grant & Hack’s Chemical Dictionary (5th Ed. 1987) at page 148. By contrast, a composition is defined as elements or compounds forming a material or produced from it by analysis. Id. In other words, a compound is a molecule with more than one element, and a composition is a mixture of two or more compounds or molecules.
The transitional term "comprising" is synonymous with "including", "containing", and "characterized by". "Comprising" is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”).
Thus, a contradiction arises within the definition of X because the Examiner finds the polyglycerol ester of polycarboxylic acids esterified with oxobutanol of instant formula (IVa) is synonymous as a "compound"; and a “compound” with this variable requires a definite chemical formula, and the open-ended term "comprises" does not exclude unrecited elements. Furthermore, "comprising", used in conjunction with "compound" fails to articulate exactly what subject matter is excluded from the claimed scope of compounds, thereby rendering the scope of claims 94-96, 99, 102, 104, and 107 indefinite.
Regarding claims 94, 95, 99, 102, 104, and 107, the claims recite the phrase, “which may be mono- or polysubstituted with one or more of the following radicals”. The use of the phrase, “may be”, introduced ambiguity into the scope of the claim, and it is unclear to the Examiner whether the polyglycerol ester of polycarboxylic acids esterified with oxobutanol of instant formula (IVa) is mono or polysubstituted. Accordingly, the metes and bounds of this claims are unclear, which rendered the claims indefinite.
Regarding claim 97, the claim recites the phrase, “especially wherein in the case of citric and the further carboxyl group present is esterified with a radical”. The Examiner finds “especially” synonymous as “preferably”, and “preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 101, the claim is dependent of claim 94, and it failed to correct the indefiniteness issue of claim 94, which rendered the claim indefinite.
Regarding claim 103, the claim is dependent of claim 102, and it failed to correct the indefiniteness issue of claim 102, which rendered the claim indefinite.
Regarding claims 105 and 106, the claims are dependent of claim 104, and they failed to correct the indefiniteness issue of claim 104, which rendered these claims indefinite.
Regarding claim 108, the claim is dependent of claim 107, and it failed to correct the indefiniteness issue of claim 107, which rendered the claim indefinite.
Claim Rejections - 35 USC § 112 fourth paragraph
The following is a quotation of the fourth paragraph of 35 U.S.C. § 112:
Subject to the following paragraph [concerning multiple dependent claims], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers (emphasis added).
Claims 98 and 100 are rejected under the fourth paragraph of 35 U.S.C. § 112 and under 37 CFR § 1.75(c), as being of improper dependent form for failing to further limit the subject matter of a previous claim. Applicant is required to cancel the claim(s), or amend the claim(s) to place the claim(s) in proper dependent form, or rewrite the claim(s) in independent form.
Regarding claims 98 and 100, the claims are dependent upon claim 94. The subject matter in claim 94 is drawn to a polyglycerol ester of polycarboxylic acids esterified with oxobutanol of instant formula (IVa). The subject matter in claims 98 and 100 is drawn to a limited embodiment of instant formula (IVa).
The scope of claims 98 and 100 is broader than scope of claim 94 because claims 98 and 100 include species that are outside of instant formula (IVa) (e.g. a radical Y-OH). Because the scope of claims 98 and 100 is broader than claim 94, the claims failed to further limit the subject matter thereof, and fail to comply with the formal requirements set forth in the fourth paragraph of 35 U.S.C § 112.
The Examiner suggests that the claims be amended in a manner such that the scope of claims 98 and 100 is commensurate with the scope of claim 94.
Claim Interpretation
The Examiner finds the claim construction of claim 92 and 93 as a product by process limitation. In other words, the patentability of the instantly claimed reaction intermediate in claim 92 and reaction product in claim 93 is based on the reaction intermediate and reaction product themselves, and not their method of preparation.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
The instant claims are drawn to reaction intermediate of a polycarboxylic acid ester of oxobutanol.
Claim 92 is rejected on the ground of nonstatutory obviousness-type double patenting (ODP) as being unpatentable over the conflicting claims of the following U.S. patents or co-pending applications. See Table below.
If the conflicting claims are in a co-pending application, then the rejection is a provisional ODP rejection because the conflicting claims have not in fact been patented.
Co-pending Application No./ U.S. Patent No.
Conflicting Claims
Provisional ODP
(Yes or No)
19/328,682
1-12
Yes
The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. See MPEP 804; In re Braat, 937 F.2d 589, 19 USPQ 2d 1290 (Fed. Cir. 1991); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). For this reason, the factual inquires set forth in Graham v. John Deere Co., 383 U.S. 1, USPQ 459 (1966) are employed herein.
The Graham v. Deere inquires are summarized as follows: (A) Determining the scope and contents of the patent claim relative to a claim in the application at issue; (B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue; (C) Determine the level of ordinary skill in the pertinent art; and, (D) Evaluate any objective indicia of nonobviousness.
(A) Determining the scope and contents of the patent claim relative to a claim in the application at issue – The conflicting claims of the abovementioned co-pending application are drawn to a method of carboxylic acid esters of 3-hydroxybutanoate of formula (III) or a method of treatment via the carboxylic acid esters of 3-hydroxybutanoate of formula (III).
(B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue - The conflicting claims of the abovementioned co-pending application described the carboxylic acid esters of 3-hydroxybutanoate of formula (III) in a method of making- or a method of treatment-type claim.
(C) Determine the level of ordinary skill in the pertinent art - the level of ordinary skill in the art may be found by inquiring into: (1) the type of problems encountered in the art; (2) prior art solutions to those problems; (3) the rapidity with which innovations are made; (4) the sophistication of the technology; and (5) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of those factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983).
Based on the typical education level of active workers in the field of organic chemistry, as well as the high degree of sophistication required to solve problems encountered in the art, the Examiner finds that a person of ordinary skill in the art would have at least a college degree in the field related to medicine, chemistry, and/or the pharmaceutical art and at least four years of work experience, i.e. a masters or doctorate level scientist/clinician.
(D) Evaluate any objective indicia of nonobviousness - none
Conclusion - Although the conflicting claims are not identical, one of ordinary skill in the art would recognize that they are not patentably distinct from each other. As recited above, the carboxylic acid esters of 3-hydroxybutanoate of formula (III) in the conflicting claims of abovementioned co-pending application is the instant reaction intermediate.
The unpredictable nature of the chemical arts generally allows an assertion of similarity to be rebutted by a sufficient demonstration of nonobviousness that employs secondary considerations of objective indicia. In this case, there are no indicia of nonobviousness shown to provide evidence that carboxylic acid esters of 3-hydroxybutanoate of formula (III) of the abovementioned co-pending application is excluded as the instant reaction intermediate of the instant application. Absent indicia of nonobviousness, the Examiner finds that one of ordinary skill in the art would consider the instant reaction intermediate and that of the conflicting claims of the abovementioned co-pending application to be equally effective in their objective.
This rejection is in agreement with the judicially created doctrine grounded in public policy to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees.
Claim Objections
Claims 92, 94-100, 102, 104, and 107 are objected to because of the following informalities:
Regarding claim 92, the claim is dependent of claim 83, and claim 92 recites the phrase, “reaction intermediate product”, which contains typographical error.
For consistency and to correct the typographical error, the abovementioned phrase should recite -- reaction intermediate
Regarding claims 94-100, 102, 104, and 107, the claims recite the phrase, “however, with the proviso that at least one radical”.
Such expression can be clarified by reciting -- --.
Appropriate correction is required.
Conclusion
Claims 82-108 are rejected.
Claims 92, 94-100, 102, 104, and 107 are objected.
Claims 1-81 are cancelled.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
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