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 -----1/22/2024, which is a national stage application of PCT/US2022/038084 filed 7/22/2022, which claims domestic priority to 63/225,401 filed 7/23/2021.
As filed, claims 1 and 111-129 are pending; and claims 2-110 are cancelled.
Election/Restrictions
Applicant’s election without traverse of Group II – Claims 1, 111-126, and 129 in the reply filed on 6/11/2026 is acknowledged.
Claims 127 and 128 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/11/2026.
Regarding the election of species requirement, Applicant elected the species of chronic lymphocytic leukemia (CLL) for the instantly claimed disease; and the species of
PNG
media_image1.png
128
338
media_image1.png
Greyscale
for the compound of instant formula (A), which can be found in pg. 96 and pg. 72 of the instant specification, respectively. The claims, which read on both elected species, are instant claims 1, 111-124, and 129, according to Applicant’s reply filed on 6/11/2026. However, the Examiner finds that claims 119-122 and 124 does not read on the elected species, while claim 126 reads on the elected species. Accordingly, only claims 1, 111-118, 123, and 126 will be examined herein.
Claims 119-122, 124, 125, and 129 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does not make a contribution over the prior art.
According to MPEP 803.02: should the elected species appear non-allowable, the search of the Markush-type claim will not be extended. The Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/12/2024 has been considered by the Examiner.
Drawings
The drawings of Figs. 1, 4, 5, and 7 are objected to because the numbering and/or texts are blurry and/or illegible. 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(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 1, 111-118, 123, and 126 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 treating disease mediated by BTK, does not reasonably provide enablement for prevent disease modulated by BTK nor for treating or prevent disease that is NOT mediated by BTK. 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/or use the invention commensurate in scope with these claims.
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:
The nature of the invention - is a method of treating or preventing any disease via a compound of instant formula (A).
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.
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.
The amount of direction or guidance presented – the instant specification briefly provides an explanation of the biological activity of BTK on pp. 1-4, including references that discuss the implication of bifunctional compounds capable of inducing proteolytic degradation of BTK with enhanced IMiD activity in the treatment of cancer, etc. There is no direction or guidance provided that supports a use of bifunctional compounds capable of inducing proteolytic degradation of BTK with enhanced IMiD activity as a broad based drug for treating or preventing any disease, as instantly embraced.
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 and preventing any disease, a vast amount of evidence is required because such a claim is not supported by the prior art or the instant specification.
The presence or absence of working examples - there are no working or prophetic examples in the specification that demonstrate that the instant compounds or composition thereof may treat or prevent any disease, as instantly embraced. The specification demonstrate that the instant compounds were tested for their IMiD activity in vitro and their efficacy in CLL with and without BTK C481 mutation, MCL MZL, WM, FL and DLBCL in vivo (pg. (pg. 93-98 of the instant specification)
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 (A) may treat or prevent any disease in a patient.
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.
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 1, 111-118, 123, and 126 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 or prevent any disease.
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 112-114 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 claims 112-114, the claim recites the phrase, “the disease or disorder” wherein the word, “the”, requires antecedent basis, and it is unclear where applicant has defined “a” disorder. Without antecedent basis, the claims are rendered indefinite.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1, 111-118, and 126 are rejected under 35 U.S.C. 103 as being obvious over Foreign Patent Application Publication No. WO2020/081450, hereinafter Robbins. See IDS filed 9/12/2024
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claims 1, 112-118, and 126:
Determining the scope and contents of the prior art:
Robbins, for instance, teaches the following compounds or pharmaceutical composition thereof that proteolytically degrade targeted C481S mutated form of BTK, which can be used to treat diseases modulated by BTK, such as chronic lymphocytic leukemia (CLL).
PNG
media_image2.png
148
616
media_image2.png
Greyscale
(pg. 133, compound 44)
PNG
media_image3.png
136
618
media_image3.png
Greyscale
(pg. 155, compound 52)
PNG
media_image4.png
82
608
media_image4.png
Greyscale
(paragraph 0002)
PNG
media_image5.png
58
618
media_image5.png
Greyscale
(paragraph 0005)
PNG
media_image6.png
162
634
media_image6.png
Greyscale
(paragraph 0337)
PNG
media_image7.png
172
626
media_image7.png
Greyscale
(pg. 410)
Although Robbins did not explicitly teach that the abovementioned compounds have enhanced IMiD activity, the Examiner finds that the abovementioned activity is an inherent feature of the compounds as taught by Robbins. According to MPEP 21121(I) and (II), the discovery of a previously unappreciated feature of the compounds, as taught by Robbins, does not render the abovementioned activity patentable to the Applicant. In addition, such inherent activity did not have to be recognized at the time of invention by Robbins.
Ascertaining of the difference between the prior art and the claim at issue:
For the elected species, the abovementioned compounds 44 and 52 of Robbins did not explicitly teach the unsubstituted piperidine ring for instant ring B.
In addition, for the abovementioned compounds 44 and 52, Robbins did not explicitly teach the administration of either compound is for at least 15 days.
Finding of prima facie obviousness --- rationale and motivation:
For the elected species, MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at 418, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
Based on the teachings of the MPEP and KSR above, by employing the rationale in (B) above, it would have been obvious to one of ordinary skill in the art to substitute
PNG
media_image8.png
67
147
media_image8.png
Greyscale
of compounds 44 and 52 of Robbins with
PNG
media_image9.png
52
56
media_image9.png
Greyscale
of compound 163 of Robbins in order to arrive at the elected species because of the preferred embodiments or blazemarks, as shown below, and there is a reasonable expectation of success that the resulting obvious variants can retain the ability to proteolytically degrade BTK with enhanced IMiD activity.
PNG
media_image10.png
142
614
media_image10.png
Greyscale
(pg. 136, compound 163)
PNG
media_image11.png
150
204
media_image11.png
Greyscale
(paragraph 0008)
PNG
media_image12.png
90
520
media_image12.png
Greyscale
(paragraph 0011)
In addition, the Examiner does not find the abovementioned administration time as result-effective variable because the Applicant fails to demonstrate this parameter to impart any unexpected or novel aspect to the instant process (i.e. no comparative example). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05. Accordingly, this parameter is viewed as routine experimentation to optimize the instant process, and not a patentable distinction.
Regarding claim 111:
Determining the scope and contents of the prior art:
Robbins, for instance, teaches the abovementioned process.
Ascertaining of the difference between the prior art and the claim at issue:
Robbins, for instance, did not explicitly teach that the administration is chronic or the frequency of the chronic administration depicted in claim 111.
Finding of prima facie obviousness --- rationale and motivation:
the Examiner does not find the abovementioned chronic administration and/or the frequency of the chronic administration as result-effective variables because the Applicant fails to demonstrate these parameters to impart any unexpected or novel aspect to the instant process (i.e. no comparative example). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05. Accordingly, these parameters are viewed as routine experimentation to optimize the instant process, and not a patentable distinction.
Nonstatutory 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 a method of treating a disease via compound of instant formula (A).
Claims 1, 111-118, 123, and 126 are 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)
12,377,106
1-18, 20-22, 24, and 25
No
In this instance, the analysis employed for the abovementioned nonstatutory obviousness-type double patenting rejection parallels the analysis for anticipation, wherein the instant method is anticipated by the method disclosed in the abovementioned conflicting claims of the abovementioned U.S. patent.
Although US12377106 did not explicitly teach that its compounds induce proteolytic degradation of BTK and has enhanced IMiD activity, the Examiner finds that the abovementioned therapeutic activities are inherent features of its compounds due to its structure. According to MPEP 2112(I) and (II), the discovery of previously unappreciated features of the compounds of US12377106 does not render the abovementioned therapeutic activities patentable to Applicant. In addition, such inherent therapeutic activities did not have to be recognized at the time of the invention by US12377106.
All of which led to the abovementioned anticipation.
Claims 1, 111-118, 123, and 126 are 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)
12,600,732
1-15 and 24
No
11,866,442
1-29 and 33-36
No
11,820,781
1-34
No
11,479,556
1-106
No
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 U.S. patents are drawn to a compound of instant formula (A) and/or a method of treatment using the compound thereof.
(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 U.S. patents described the compound of instant formula (A) in a different Markush structure and/or in a method of treatment-type claim. In addition, the abovementioned U.S. patents did not explicitly describe their compounds capable of inducing proteolytic degradation of BTK or their compounds having enhanced IMiD activity.
(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 because they are drawn to the same compound having the same therapeutic utility (e.g. inducing proteolytic degradation of BTK, etc.). As a result, an infringer of a patent issuing from the instant claims would also be an infringer of the conflicting claims of the abovementioned U.S. patents.
As recited above, the compound in the conflicting claims of abovementioned U.S. patents is the compound of instant formula (A). However, these conflicting claims may have different Markush structures of instant formula (A) and/or are drawn to a compound-type claims
Structural similarity is the touchstone of the nonobviousness inquiry for patents claiming a novel chemical compound. Eisai Co. v. Dr. Reddy's Laboratories, 533 F.3d1353,1356-57 (Fed. Cir. 2008). In this case, the compounds are the same; i.e., they have the same atomic composition and the same atomic connectivity. For this reason, one of ordinary skill in the art would anticipate that this is the same compound.
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 the structure of the abovementioned U.S. patents is excluded as the compound of instant formula (A) of the instant application. Absent indicia of nonobviousness, the Examiner finds that one of ordinary skill in the art would consider the instant compound forms and that of the conflicting claims of the abovementioned U.S. patents to be equally effective in their objective.
In addition, although the abovementioned U.S. patents did not explicitly teach that their compounds induces proteolytic degradation of BTK and have enhanced IMiD activity, the Examiner finds that the abovementioned activities are inherent features of the compounds as taught by the abovementioned U.S. patents. According to MPEP 21121(I) and (II), the discovery of a previously unappreciated features of the compounds, as taught by the abovementioned U.S. patents, did not render the abovementioned activities patentable to the Applicant. In addition, such inherent activities did not have to be recognized at the time of invention by the abovementioned U.S. patents.
Lastly, the Examiner does not find the administration time of at least 15 days, the chronic administration, and the frequency of the chronic administration as result-effective variables because the Applicant fails to demonstrate these parameters to impart any unexpected or novel aspect to the instant process (i.e. no comparative example). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05. Accordingly, these parameters are viewed as routine experimentation to optimize the instant process, and not a patentable distinction.
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.
Conclusion
Claims 1, 111-118, 123, and 126 are rejected.
Claims 119-122, 124, 125, and 127-129 are withdrawn.
Claims 2-110 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
Prosecution Insights