DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/15/2024 has been entered.
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restriction
The rejections of record have been withdrawn below.
Applicants canceled claims 2-26.
Examiner has extended the Markush Search to salbutamol.
Current Status of 17/274,175
This Office Action is responsive to the amended claims of 6/15/2024.
Claims 1 and 27-28 have been examined on the merits.
Claim 1 is currently amended. Claims 27-28 are new.
Priority
The instant application is a national stage entry of PCT/US/050120, filed on 09/07/2019, which claims priority to 62/728,800, filed on 09/09/2018.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claims have support from 62/728,800 therefore 09/09/2018 is assigned as the instant application’s effective filing date.
Information Disclosure Statement
No IDS has been filed.
Response to Arguments
The Examiner acknowledges receipt of Applicants’ claim amendments and Reply of 6/15/2024.
The Examiner has reviewed the claim amendments and Reply of 6/15/2024.
In regard to the obviousness rejection, Examiner withdraws this rejection. Applicant have narrowed the scope of compounds of claim 1.
Examiner has reviewed the original specification and the amendments have written support at the cites Applicant point out.
In regard to the objection to claim 1, Applicant amended claim 1 as Examiner had suggested.
In regard to the anticipatory rejection, Examiner withdraws this rejection. Claim 1 as currently amended does not allow for ephedrine.
In regard to the obviousness rejection, Examiner withdraws this rejection. Claim 1 as currently amended does not allow for ephedrine.
Response to Amendment
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. Because the invention is no longer directed to IBD’s extra intestinal manifestations, Examiner recommends “Treatment of Inflammatory bowel disease”.
Claim Objections
Claim 28 is objected to because of the following informalities: Claim 28 has a list of places in the colon (things that could be colon specimens). Inflammatory cell infiltration is not a place in the colon. Claim 28’s lacks parallelism, which makes the claim awkward. Examiner recommends deleting “inflammatory cell infiltration”.
Claim Rejections - 35 USC § 112
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.
Claim 1 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163 states that, “[n]ew or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389,1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).” Further, the MPEP states, “[w]hile there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure.”
Here, Examiner thoroughly reviewed the original claims and Specification of 7 March 2021 but could not find the limitation “selected” β-phenethanolamine derivative as currently being used in base claim 1. Thus, there is no express disclosure.
Moreover, there is no implicit or inherent disclosure for “selected” β-phenethanolamine derivative within either the original claims or Specification since the artisan would not reasonably be expected to assume what a “selected” β-phenethanolamine derivative is.
Thus, claim 1 is rejected for lacking written description for “selected” β-phenethanolamine derivative.
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 and 27-28 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.
The term “selected B2-adrenergic receptor agonist” in claim 1 is a relative term which renders the claim indefinite. The term “selected B2-adrenergic receptor agonist” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term is not defined in the specification or in the prior art. Examiner recommends deleting the word “selected”.
Claim 1 recites the limitation “including salbutamol… clenbuterol”, which is unclear and thus indefinite. Examiner does not know if the list of agonists are merely exemplary or required. Examiner recommends amending claim 1 so that it reads “ B2-adrenergic receptor agonist selected from salbutamol… clenbuterol”. See MPEP 2117(I) for more information on formatting proper Markush groups.
Claim 1 also recites the limitation “including increments… untreated IBD”, which is unclear and thus indefinite. Examiner does not know if this limitation is exemplary or required by the claim. Additionally, there is no active verb relating this phrase to the rest of the claim. Applicants needs to add a verb such as “measuring”.
Claim 1’s limitation “including increments… untreated IBD” is unclear and indefinite. Examiner is aware of three different situations that could be measured and compared. There is (A) IBD treated with R-enantiomer, (B) IBD treated with S-enantiomer, and (C) untreated IBD. Examiner does not know which group Applicant means to compare: A/B, B/C, or A/C.
Claim 28’s limitation “including epithelia…lamina propria” is unclear and indefinite. Examiner does not know if this list of possible colon specimens are required by the claim or merely examples.
Claim Interpretation
For the purposes of examination and because claims 1 and 27-28 are indefinite, Examiner is interpretating claim 1 to be including measuring R-enantiomer treated patient’s increments of both disease active index and histological score of IBD compared to an untreated patient’s increments of both disease active index and histological score of IBD. This is version A/C as defined in the indefinite rejection above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over:
WO2016078609
In view of
MAYO CLINIC (“Ulcerative Colitis”, Mayo Clinic, January 20, 2016),
As relied upon
NIH (“General Structure of Digestive System”, NIH, June 30, 2002),
In view of
MOSLI (Mosli et al., “Histologic scoring indices for evaluation of disease activity in ulcerative colitis, Cochrane Library, published 2017)
And in view of
KURIYAMA (Kuriyama et al., “Prediction of Flare-ups of ulcerative colitis using quantitative immunochemical fecal occult blood test”, World of Journal of Gastroenterology, March 7, 2010).
Determining the scope and contents of the prior art
WO2016078609 teaches levalbuterol (the optically pure R-enantiomer of salbutamol) used to treat mucosal membrane ulcers (paragraph [0001-0002], title, claim 7).
WO2016078609 teaches that the different enantiomers have opposite properties (paragraph [0002]).
MAYO CLINIC teaches ulcerative colitis is an inflammatory bowel disease that causes ulcers in your digestive treat (page 2). MAYO CLINIC teaches that ulcerative colitis affects the innermost lining of your large intestine (page 2).
NIH is relied upon for the beneficial teaching that the innermost lining of your large intestine is a mucous membrane layer (page 1).
MOSLI teaches that taking a tissue sample (biopsy) is routine for ulcer colitis in evaluating a histologic scoring index, which is used to assess the patient’s disease severity (page 3). This helps teach claim 28.
MOSLI teaches Histology plays an important role in diagnosing UC and can serve as a tool to determine response to therapy (page 3). MOSLI teaches comparing treated and untreated patients’ scores (page 3).
KURIYAMA teaches that the fecal occult blood test is used to characterize severity of ulcerative colitis in a patient (abstract). KURIYAMA teaches comparing the scores of treated and untreated patients’ scores (abstract). This teaches the disease active index is known. This helps teach claim 27.
Ascertaining the differences between the prior art and the claims at issue
While WO2016078609 teaches levalbuterol (the optically pure R-enantiomer of salbutamol) used to treat mucosal membrane ulcers (paragraph [0001-0002], title, claim 7), WO2016078609 does not teach measuring histology or disease active index.
While MAYO CLINIC teaches ulcerative colitis is an inflammatory bowel disease that causes ulcers in your digestive treat (page 2), and teaches that ulcerative colitis affects the innermost lining of your large intestine (page 2), MAYO CLINIC does not teach levalbuterol.
While MOSLI teaches that taking a tissue sample (biopsy) is routine for ulcer colitis in evaluating a histologic scoring index, which is used to assess the patient’s disease severity (page 3), MOSLI does not teach levalbuterol.
While KURIYAMA teaches that the fecal occult blood test is used to characterize severity of ulcerative colitis in a patient (abstract), KURIYAMA does not teach levalbuterol.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the administration of beta-phenethanoamine derivatives useful in treating IBD, and possesses the technical knowledge necessary to make adjustments to the combination compositions to optimize the pharmacokinetic doses of beta-phenethanoamine derivatives. Said artisan has also reviewed the problems in the art as regards to bioavailability of these combination compositions and understands the solutions that are widely-known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
The instant claims are prima facie obvious in light of the combination of references.
The artisan would have found it obvious to administer levalbuterol (the optically pure R-enantiomer of salbutamol) in order to treat inflammatory bowel disease (IBD). Ulcerative colitis (a type of inflammatory bowel disease) causes ulcers in the innermost mucous lining of one’s intestine (MAYO CLINIC page 2 and NIH page 1). The artisan would expect that levalbuterol would treat mucosal membrane ulcers (WO2016078609 paragraph [0001-0002], title, claim 7). The artisan would further expect that levalbuterol would be effective at treating mucosal membrane ulcers in the intestine. By treating intestine ulcers, levalbuterol would also treat IBD. This teaches claim 1.
The artisan would also be expected to measure an increment of disease active index (such as fecal occult blood) in order to evaluate the severity of IBD. KURIYAMA teaches that the fecal occult blood test is used to characterize severity of ulcerative colitis in a patient (abstract). KURIYAMA teaches comparing the scores of treated and untreated patients’ scores (abstract). The artisan would be motivated and expected to use a known evaluative technique. This teaches claim 27.
The artisan would also be expected to measure a histological score of IBD (such as taking a damaged colon specimen) in order to evaluate the severity of IBD. MOSLI teaches that taking a tissue sample (biopsy) is routine for ulcer colitis in evaluating a histologic scoring index, which is used to assess the patient’s disease severity (page 3). MOSLI teaches comparing treated and untreated patients’ scores (page 3). This teaches claim 28.
Conclusion
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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/GILLIAN A HUTTER/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625