DETAILED ACTION
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 .
Claims 1-12 are currently pending in this Application.
Priority
CONTINUING DATA
This application is a 371 of PCT/GB2023/051618 06/21/2023
FOREIGN APPLICATIONS
UNITED KINGDOM 2209281.1 06/24/2022
Information Disclosure Statement
Applicant’s Information Disclosure Statement, filed on December 23, 2024 and March 03, 2025 has been considered. Please refer to Applicant’s copies of the 1449 submitted herewith.
Claim Rejections - 35 USC § 112
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.
The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
Claims 2, 4, 6, 9 and 12, 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 pre-AIA the applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance:
Claims 2, recites the broad recitation “…in the range from 4 % w/w to about 8 % w/w” and the claim also recites “preferably in the range from about 5.5 % w/w to about 7 % w/w” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
Claim 4, recites the broad recitation “…in the range from 1 % w/w to about 10 % w/w” and the claim also recites “preferably in the range from about 2 % w/w to about 7.5 % w/w” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
Claim 6, recites the broad recitation “…in the range from 30 % w/w to about 99 % w/w” and the claim also recites “preferably in the range from about 60 % w/w to about 90 % w/w” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
Claim 9 recites the broad recitation “ .. spasticity resulting from multiple sclerosis” and the claim also recites “particularly for the relief of flexor spasms …” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
Claim 12 recites the broad recitation “ … disintegrating time is less than 3 minutes” and the claim also recites “preferably less than one minute” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
It is recommended that Applicant remove the narrow limitations of the claims in all instances. Applicants can also add a new claim with the narrow limitations.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-7, 9 and 12 are rejected, under 35 U.S.C. 102(a)(1) as being anticipated by RADKE et al "FORMULATION AND EVALUATION OF ORODISPERSIBLE TABLETS OF BACLOFEN", INTERNATIONAL JOURNAL OF CHEMTECH RESEARCH, vol. 1, no. 3, 1 July 2009 (2009-07-01), pages 517-521
Claim 1, is directed to an orodispersible pharmaceutical composition comprising Baclufen, and at least one disintegrant and one diluent.
Claims 2-7 and 12 further define the orodispersible pharmaceutical composition, the disintegrant, the diluent and the presence of additional ingredients.
Claim 9 recites an intended use of the composition.
Radke et al teaches orodispersible pharmaceutical composition comprising Baclufen that read directly on the instantly claimed orodispersible pharmaceutical composition.
Radke et al, (see table 1), teach orodispersible formulation comprising:
Baclofen; disintegrants (Ac-Di-Sol comprising croscarmellose sodium, Crospovidone or sodium starch glycosylate); diluents (mannitol and microcrystalline cellulose); sweetener (aspartame); and lubricant (magnesium stearate) in the same range of the mass ratio.
In regard to claim 9, the limitation “for treatment of spasticity …” is an intended use limitation as governed by MPEP §2111.02(II). Intended use limitations are interpreted based on the structural limitations they impart to the invention. In this case, the intended use only requires orodispersible pharmaceutical composition comprising Baclufen, and at least one disintegrant and one diluent for the treatment of spasticity in a human subject but does not impart any specific limitations to the structure. A chemical composition and its properties are inseparable.
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Claim Rejections - 35 USC § 103
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.
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 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1-12 are rejected under 35 U.S.C. 103(a) as being unpatentable over R. RADKE et al "FORMULATION AND EVALUATION OF ORODISPERSIBLE TABLETS OF BACLOFEN", INTERNATIONAL JOURNAL OF CHEMTECH RESEARCH, vol. 1, no. 3, 1 July 2009 (2009-07-01), pages 517-521 in view of MISHRA SAURABH M ET AL: "Effect of Physical Properties and Chemical Substitution of Excipient on Compaction and Disintegration Behavior of Tablet: A Case Study of Low-Substituted Hydroxypropyl Cellulose (L- HPC)", MACROMOL, vol. 2, no. 1, 4 March 2022 (2022-03-04), pages 113-130
Claim 1, is directed to an orodispersible pharmaceutical composition comprising Baclufen, and at least one disintegrant and one diluent.
Claims 2-8 and 12 further define the orodispersible pharmaceutical composition, the disintegrant, the diluent and the presence of additional ingredients.
Claim 9 recites an intended use of the composition.
Claims 10 and 11 are directed to a method of preparing the composition.
Determination of the scope and contents of the prior art
Radke et al, (see table 1), teach orodispersible formulation comprising:
Baclofen; disintegrants (Ac-Di-Sol comprising croscarmellose sodium, Crospovidone or sodium starch glycosylate); diluents (mannitol and microcrystalline cellulose); sweetener (aspartame); and lubricant (magnesium stearate) in the same range of the mass ratio. Radke et al also teaches the method of preparation of the composition.
Radke et al, does not teach the presence of low substituted hydroxypropyl cellulose (L-HPC) in the orodispersible formulation.
MISHRA SAURABH M ET AL teach L-HPC is a well-known binder and disintegrant in the field of pharmaceutical compositions.
Resolving the Level of Ordinary Skill in the Pertinent Art
“Factors that may be considered in determining level of ordinary skill in the art include: (1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) the education level of active workers in the field.” Envtl. Designs, Ltd. V. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.3d 1376, 1381-82 (Fed. Cir. 1983)). The above factors are not exhaustive but are a guide. Id.
In this case, the education level of the inventor and the 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, a person of ordinary skill in the art would likely have at least a college degree in the field of organic chemistry, with industry experience, i.e., a masters or doctorate level of skill and knowledge in the laboratory. Thus, the level of skill in the art is relatively high.
Finding of prima facie obviousness
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143. Examples of 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.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel. Here one or more of rationales (C) and (G) apply.
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to use the teachings of Radke et al. and MISHRA SAURABH M ET AL to explore adding L-HPC to the orodispersible pharmaceutical composition as the instantly claimed invention. One skilled in the art would have been motivated to consider adding other ingredients such as L-HPC to get additional orodispersible pharmaceutical composition products.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Accordingly, claims 1- 12 are rendered obvious in view of the references above. Applicant may wish to consider providing evidence of unexpected results to overcome the obviousness rejection.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMAL A SAEED whose telephone number is (571) 272-0705.
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, Adam C Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kamal A Saeed/
Primary Examiner, Art Unit 1626
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