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 .
Election/Restrictions
Applicant’s election of Group I, corresponding to claims 1-15, in the reply filed on July 16, 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Applicant canceled claimed 16-20 drawn to Group II.
Claim of Foreign Priority
Applicant’s claim of foreign priority to application number GB 2301180.2 and copies of certified priority documents are acknowledged by the Office.
Status of the Claims
Claims 1-15 are pending and examined.
Allowable Subject Matter
Claims 3-7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112
Claims 8 and 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the claimed dependent limitations below are purely functional recitation with no additional limitation of structure for a further limiting claim. For example, these claims recite:
1. “has a melting point of at least 80°C; and
2. “has a melting point of at least 85°C.”
The above examples are the dependent limitations, which are required to be further limiting, although there are no further limiting structural limitations. A functional result is merely claimed.
These functional recitations therefore include any and all possible structures (composition ingredients and formulation techniques) to achieve the result/function. This type of claiming results in a single means claim, i.e., where a means recitation does not appear in combination with another recited element of means, is subject to an enablement rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714-715, 218 USPQ 195, 197 (Fed. Cir. 1983) (A single means claim which covered every conceivable means for achieving the stated purpose was held nonenabling for the scope of the claim because the specification disclosed at most only those means known to the inventor.). When claims depend on a recited property, a fact situation comparable to Hyatt is possible, where the claim covers every conceivable structure (means) for achieving the stated property (result) while the specification discloses at most only those known to the inventor.
Applicant is reminded that 35 U.S.C. § 112, sixth paragraph, when enacted, was a statutory response to the Supreme Court’s decision in Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946); and was a way to use to limit the scope to what the inventor described in the specification.
This general prohibition against the use of “purely functional claim language” (and the more specific Halliburton rule) has not been completely eliminated. Rather, “purely functional claim language” is now permissible but only under the conditions of 35 U.S.C. § 112, sixth paragraph, i.e., if its scope is limited to the corresponding structure, material, or act disclosed in the specification and equivalents thereof.
In the absence of such limited construction, the concerns expressed by the Court in Halliburton are still applicable to prohibit the use of “purely functional” claim language. Hence, any claim that includes purely functional claim language, and which is not subject to the limited construction under 35 U.S.C. § 112, sixth paragraph, fails to meet the requirements of 35 U.S.C. § 112, first paragraph, according to reasoning in Halliburton and thus is unpatentable.
While the particular claim language involved in the Supreme Court's Halliburton decision uses the word “means,” the issue was claiming in a purely functional manner, a practice condemned by pre-existing case law, and not any particular problem associated uniquely with the word “means” as distinguished from other purely functional words and phrases. With regard to pre-existing case law around the time of the Supreme Court's Halliburton decision, see In re Fuetterer, 319 F.2d 259, 263 (CCPA 1963), wherein the Court of Customs and Patent Appeals explained:
In the Fullam case [In re Fullam, 161 F.2d 247 (CCPA 1947)], this court stated that some claims were properly rejected as “functional in claiming merely the desired result well known to and sought after by workers skilled in the art.” Claims directed merely to a “desired result” have long been considered objectionable primarily because they cover any means which anyone may ever discover of producing the result. See, e.g., O'Reilly v. Morse, 15 How. 62; Heidbrink v. McKesson, 290 F. 665.
When an applicant has not given notice to the public that his or her purely functional claim element is to be limited by the application of 35 U.S.C. § 112, sixth paragraph, a first USPTO concern is that the claim is indefinite under 35 U.S.C. § 112, second paragraph. A second USPTO concern is that such unlimited purely functional claiming may reasonably be construed to encompass any and all structures for performing the recited function, including those which are not what the applicant invented. Thus, it is doubly critical that the USPTO be in possession of such public notice when making a determination to grant a patent. That is, when the limitation encompasses any and all structures or acts for performing a recited function, including those which were not what the applicant had invented, the disclosure fails to provide a scope of enablement commensurate with the scope of the claim and the claim would violate the prohibition of Halliburton.
The Supreme Court’s Halliburton case remains viable for claims having purely functional claim language which is unlimited either by (1) the application of 35 U.S.C. § 112, sixth paragraph, or (2) the additional recitation of structure.
In the present case, these claim limitations violate the rule set forth in Halliburton, because the claims are not limited by the application of 35 U.S.C. § 112, sixth paragraph, and they do not contain any additional recitation of structure. As such, these claims are unpatentable under 35 U.S.C. § 112, first paragraph, for lack of an enabling disclosure commensurate with the scope of the claims.
Without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim. Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc). See also Datamize LLC v. Plumtree Software Inc., 75 USPQ2d 1801 (Fed. Cir. 2005) where a claim directed to a software based system for creating a customized computer interface screen recited that the screen be "aesthetically pleasing," which is an intended result and does not provide a clear cut indication of scope because it imposed no structural limits on the screen. Unlimited functional claim limitations that extend to all means or methods of resolving a problem may not be adequately supported by the written description or may not be commensurate in scope with the enabling disclosure, both of which are required by 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714, 218 USPQ 195, 197 (Fed. Cir. 1983); Ariad, 598 F.3d at 1340, 94 USPQ2d at 1167. For instance, a single means claim covering every conceivable means for achieving the stated result was held to be invalid under 35 U.S.C. 112, first paragraph because the court recognized that the specification, which disclosed only those means known to the inventor, was not commensurate in scope with the claim. Hyatt, 708 F.2d at 714-715, 218 USPQ at 197. For more information regarding the written description requirement and enablement requirement under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, see MPEP §§ 2161-2164.08(c). Examiners should keep in mind that whether or not the functional limitation complies with 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is a different issue from whether the limitation is properly supported under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, or is distinguished over the prior art.
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.
Claims 1, 2, and 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Coats et al., (WO2017/144977 A1) (cited in IDS of July 17, 2025, foreign reference #5), in view of Alexander et al., (US2002/0123485), and in view of Zölss et al., (U.S. Pat. No. 4,767,784).
Coats teaches beta-blockers including oxprenolol for treating a number of conditions. See par. 4. Further, Coats teaches compositions with enantiomeric excess of S-oxprenolol, including those with at least 99.9% enantiomeric excess of S-oxprenolol. See par. 13. Pharmaceutically acceptable salts are contemplated to include those with organic and inorganic counterions including many known in the art. See par. 37. Coats teaches embodiments comprising pharmaceutically acceptable carriers and excipients, including diluents. See par. 74. Unit dosages in the form of a tablet are contemplated. See par. 75.
Coats does not teach a phosphate salt or an acid addition salt of comprising phosphoric acid.
Alexander teaches composition and method using a beta-adrenergic antagonist, including oxprenolol, among others. See par. 60. The active components can be in the form of a pharmaceutically acceptable salt with a variety of inorganic acids, including phosphoric acid. “Examples of such inorganic acids are hydrochloric, hydrobromic, hydroiodic, nitric, carbonic, sulfuric and phosphoric acid.” Par. 70. A total of 7 inorganic acids are listed.
Alexander does not teach a crystalline form.
Zölss teaches pharmaceutically acceptable salts of beta blockers, including oxprenolol. See col. 4, lines 59-60. Zölss notes, “Because of their excellent tendency toward crystallization and the particularly pronounced purification effect, the novel salts of the general formula I of the following…are particularly preferred….” Oxprenolol is listed thereafter. See col. 4, lines 40-44 and 59, 60. Acids which are suitable for salt formation include phosphoric acid. See col. 8, line 47. Example 32 provides a method to create a crystalline form of oxprenolol. See col. 17, lines 61-68.
With regard to claims 8 and 9, absent evidence to the contrary or a claimed distinguishing structural limitation included in the claim, a phosphoric acid addition salt of S-oxprenolol as rendered obvious by the prior art would have chemical properties associated therewith. This is inclusive of a melting point above 80 and 85°C.
With regard to claim 10, the prior art teaches crystallizing a form of claimed acid addition salt. A crystalline form of acid addition salt of S-oxprenolol and phosphoric acid would comprise exclusively a pure form of the same. The composition of claim 10 and independent claim 1 therefore do not require additional components. This is interpreted as comprising at least 60% by weight of the overall composition because the overall composition can include the crystalline form itself.
It would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to combine the teachings of Coats, Alexander, and Zölss to arrive at an acid addition salt comprising S-oxprenolol and phosphoric acid. The examiner interprets the transitional phrase of claim 1 to be open-ended. Coats provides motivations to select S-oxprenolol or a pharmaceutically acceptable salt thereof and teaches embodiments comprising enantiomeric excess of the same to be advantageous. Such excess includes at least 99.9% S-oxprenolol. Alexander teaches acid addition salts of oxprenolol to include a phosphoric acid form. Similarly and independently, Zölss teaches phosphoric acid to be an acceptable acid addition salt for oxprenolol and notes that oxprenolol, among others, has an excellent tendency toward crystallization and the particularly pronounced purification effect renders the novel salts described as particularly preferred. As such, there is a reasonable and predictable expectation of success in arriving at an acid addition salt of phosphoric acid and S-oxprenolol in crystalline form in view of a described tendency towards crystallization, purity of such form, advantages of S-oxprenolol enantiomer, and multiple references teaching phosphoric acid as a usable acid addition salt.
As such, claims 1, 2, and 8-15 are rejected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628