DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-62 have been canceled.
Claims 63-82 are currently pending.
Election/Restrictions
Applicant’s election with traverse of Group I, Claims 63-74, and of species 0.005 to 1.0% w/w trypsin, 20 to 70% w/w glycerol, 1.0 to 65% w/w xylitol, 0.0001 to 1.5% w/w hyaluronic acid, 0.002 to 0.2% w/w CaCl₂, and 0.01 to 1.2% w/w buffer (the composition of claim 70), in the reply filed on 5/19/2026 is acknowledged. The traversal is on the ground(s) that the office action does not identify in Ye a teaching of the common technical feature of the claims being the composition of claim 63. This is not found persuasive because as indicated by the rejections below, the groups do not share the special technical feature which contributes over the prior art at the time the invention was made.
The requirement is still deemed proper and is therefore made FINAL.
Claims 64-67, 69, 71-73, and 75-82 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claims.
Claims 63, 68, 70, and 74 are being examined in this application, insofar as they read on the elected species of 0.005 to 1.0% w/w trypsin, 20 to 70% w/w glycerol, 1.0 to 65% w/w xylitol, 0.0001 to 1.5% w/w hyaluronic acid, 0.002 to 0.2% w/w CaCl₂, and 0.01 to 1.2% w/w buffer.
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.
Claims 70 and 74 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.
Claim 70, line 1-2, the recitation of “comprising or consisting of” fails to distinctly point out and define the subject matter that applicant regards as the invention. The phrases have very different meanings, so to use them in the alternative is considered indefinite.
Claim 74, line 2, the recitation of “for example” is indefinite as it is unclear if the limitation that follows is required to meet the scope of the invention.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 63, 68, 70, and 74 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 63 is directed to a composition comprising: 0.005 to 1.0% w/w trypsin; 20 to 70% w/w glycerol; and 1.0 to 65% w/w xylitol. Trypsin, glycerol and xylitol are naturally occurring. There is no indication in the instant specification that the claimed trypsin, glycerol and xylitol have any characteristics that are different from the naturally occurring trypsin, glycerol and xylitol, respectively. Thus, trypsin, glycerol and xylitol do not have markedly different characteristics from their natural counterparts in their natural state, and are “product of nature” exceptions. Accordingly, claim 63 is directed to an exception. In addition, claim 63 recites the concentration of claimed components and does not include any additional features that could add significantly more to the exception. Therefore, claim 63 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 68 recites the pH and does not include any additional features that could add significantly more to the exception. Therefore, claim 68 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 70 recites the composition comprising or consisting of: 0.005 to 1.0% w/w trypsin; 20 to 70% w/w glycerol; 1.0 to 65% w/w xylitol; 0.0001 to 1.5% w/w hyaluronic acid; 0.002 to 0.2% w/w CaCl2; and 0.01 to 1.2% w/w buffer. Trypsin, glycerol, xylitol, hyaluronic acid, CaCl2, and buffer are naturally occurring. There is no indication in the instant specification that the claimed trypsin, glycerol, xylitol, hyaluronic acid, CaCl2, and buffer have any characteristics that are different from the naturally occurring trypsin, glycerol, xylitol, hyaluronic acid, CaCl2, and buffer, respectively. Thus, trypsin, glycerol, xylitol, hyaluronic acid, CaCl2, and buffer do not have markedly different characteristics from their natural counterparts in their natural state, and are “product of nature” exceptions. Accordingly, claim 70 is directed to an exception. In addition, claim 70 recites the concentration of claimed components and does not include any additional features that could add significantly more to the exception. Therefore, claim 70 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 74 recites the form of the composition, which can be a liquid. Trypsin, glycerol, xylitol, hyaluronic acid, CaCl2, and buffer are naturally occurred as a liquid, or naturally found in liquid, or dissolve in liquid. Claim 74 does not include any additional features that could add significantly more to the exception. Therefore, claim 74 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
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 of this title, 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.
Claims 63, 68, 70, and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Clarsund et al (US 2019/0343932 A1; 11/14/2019.).
The instant claims recite a composition comprising: 0.005 to 1.0% w/w trypsin; 20 to 70% w/w glycerol; and 1.0 to 65% w/w xylitol.
Clarsund teaches a composition comprising 300000 U of trypsin, 50 L of glycerol, 1 L of buffer (para 0210). In another example, 0.2 U/ml of trypsin is mixed in 50% glycerol, 1 mM CaCl2, 20 mM Tris-HCl, pH 8.0 to a final volume of 200 µl (para 0271). The composition comprises a Tris buffer together with one or more of xylitol and glycerol (para 0182). The composition is formulated together with one or more excipients (para 0168) including hyaluronic acid for viscosity control, for achieving bioadhesion, or for protecting the lipid from chemical and proteolytic degradation (para 0173, 0180). The composition is formulated as a nasal spray, lozenge, pastille, chewing gum, gel, or liquid (para 0180, 0185).
Clarsund does not teach the claimed amounts (claims 63 and 70).
However, Clarsund does teach 300000 U or 0.2 U/ml of trypsin, 50% glycerol, 1 L of buffer or 20 mM Tris-HCl, the one or more excipients including hyaluronic acid is for viscosity control, achieving bioadhesion, or protecting the lipid from chemical and proteolytic degradation, and CaCl2 is a stabilizer (para 0174). In addition, Clarsund does teach a predetermined quantity of active material is calculated to produce a desired therapeutic effect in association with the required additive and diluent, a therapeutically effective amount is sufficient to cause an improvement in a clinically significant condition in a host, as is appreciated by those skilled in the art, the amount of a compound may vary depending on its specific activity (para 0189).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate an optimized amount of the claimed components, since Clarsund discloses that a therapeutically effective amount can be determined by the ordinary skilled medical or veterinary worker based on patient characteristics, such as age, weight, sex, condition, complications, other diseases, etc., as is well known in the art (para 0189). Generally, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. (MPEP 2144.05 II) Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to incorporate an optimized amount of the claimed components with a reasonable expectation for successfully obtaining a composition.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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, Curtis Mayes can be reached on (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Lynn Y Fan/
Primary Examiner, Art Unit 1759
Prosecution Insights