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 15-16, 18 and 22-23 have been canceled.
Claims 1-14, 17, 19-21, and 24-25 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-13 and 25, and of species Ceftazidime, a hyaluronidase comprising the amino acid sequence set forth in SEQ ID NO: 2, subcutaneous administration, and a combination of a phosphate buffer at a concentration of 1-100 mM, trehalose, mannitol, and methionine as stabilizers at a concentration of 1-500 mM, and polysorbate 20 as a nonionic surfactant at a concentration of 0.01-0.1% w/v, in the reply filed on 5/20/2026 is acknowledged.
Claims 5, 14, 17, 19-21, and 24 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking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 1-4, 6-13 and 25 are being examined in this application, insofar as they read on the elected species of Ceftazidime, a hyaluronidase comprising the amino acid sequence set forth in SEQ ID NO: 2, subcutaneous administration, and a combination of a phosphate buffer at a concentration of 1-100 mM, trehalose, mannitol, and methionine as stabilizers at a concentration of 1-500 mM, and polysorbate 20 as a nonionic surfactant at a concentration of 0.01-0.1% w/v.
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.
Claim 25 is 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 25, line 2, recites the limitation “the recombinant human HAase”. There is insufficient antecedent basis for this limitation in the claim. Applicant is required to amend the claim so as to provide proper antecedent basis for this language in the claim.
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 1-4, 6-13 and 25 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 1 is directed to a composition comprising an antibiotic and hyaluronidase (HAase). As disclosed in the instant specification, the antibiotic and HAase are naturally occurring. There is no indication in the instant specification that the claimed antibiotic and HAase have any characteristics that are different from the naturally occurring antibiotic and HAase, respectively. Thus, the antibiotic and HAase do not have markedly different characteristics from their natural counterparts in their natural state, and are “product of nature” exceptions. Accordingly, claim 1 is directed to an exception. Claim 1 does not include any additional features that could add significantly more to the exception. Therefore, claim 1 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 2 recites concentrations of the claimed antibiotic and HAase, and does not include any additional features that could add significantly more to the exception. Therefore, claim 2 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claims 3-4 recite lists of antibiotics, which can be naturally occurring. Claims 3-4 do not include any additional features that could add significantly more to the exception. Therefore, claims 3-4 do not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 6 recites enzyme activity of the claimed HAase, and does not include any additional features that could add significantly more to the exception. Therefore, claim 6 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claims 7-8 recite outcomes after administration of the composition comprises the claimed antibiotic and HAase, and do not include any additional features that could add significantly more to the exception. Therefore, claims 7-8 do not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claims 9-12 recite additional components including a buffer, a stabilizer, a nonionic surfactant, a co-solvent, a preservative, and/or an excipient. These additional components can be naturally occurring. Claims 9-12 do not include any additional features that could add significantly more to the exception. Therefore, claims 9-12 do not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 13 recites a form of the composition. The claimed antibiotic and HAase can occur naturally in liquid environments. Claim 13 does not include any additional features that could add significantly more to the exception. Therefore, claim 13 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 25 recites a specific HAase, which occurs naturally. Claim 25 does not include any additional features that could add significantly more to the exception. Therefore, claim 25 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-4, 6-13 and 25 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Wei et al (US 2016/0362670 A1; 12/15/2016.).
The instant claims recite a pharmaceutical composition for an intradermal or subcutaneous administration, comprising an antibiotic and hyaluronidase (HAase).
Wei teaches pharmaceutical compositions for a subcutaneous administration (para 0440, 0498), comprising a PH20 polypeptide (hyaluronidase (HAase)) formulated with other agents and/or with other components (para 0037), said other agents and/or other components comprise Ceftazidimes (an antibiotic) (para 0042), wherein the PH20 polypeptide is in an amount between or about between 300 Units/mL to 2000 U/mL (para 0493). Said pharmaceutical compositions comprise one or more adjuvant(s) (para 0443), phosphate buffer (para 0041, 0444) at concentrations between or about between 1 mM to 100 mM (para 0041, 0459), trehalose (para 0468), mannitol (para 0468), methionine at concentrations between or about between 5 mM to 50 mM (para 0041, 0473), surfactants such as polysorbate 20 (para 0468) between from or between about from 0.01% to 0.1% w/v (para 0470), wherein said pharmaceutical compositions are lyophilized preparation or liquid preparation (para 0434, 0440, 0494). The PH20 polypeptide contains the sequence of amino acid residues as set forth in any of SEQ ID NOS: 32-66 (para 0009), which read on SEQ ID NO:2, see Search results filed on 06/02/2026 – 20260602_083939_us-18-291-230-2.rai file, RESULT 2: 66 DUPLICATES: US-15-226-489A-49.
Claims 7 and 8 recite intended use. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103. (MPEP 2112)
Therefore the reference anticipates the claimed subject matter.
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 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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Wei et al (US 2016/0362670 A1; 12/15/2016.) as applied to claims 1, 3-4, 6-13 and 25 above.
Wei does not teach the claimed antibiotic amount (claim 2).
However, Wei does teach the claimed antibiotic, Ceftazidimes (para 0042). In addition, Wei does teach the percentage of active compound is highly dependent on the specific nature thereof, as well as the activity of the compound and the needs of the subject (para 0442).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the amount of Ceftazidimes, an antibiotic, since Wei discloses that said pharmaceutical compositions comprise Ceftazidimes, and that the percentage of active compound is highly dependent on the specific nature thereof, as well as the activity of the compound and the needs of the subject. 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 optimize the amount of Ceftazidimes with a reasonable expectation for successfully obtaining pharmaceutical compositions.
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.
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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.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
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