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 .
Applicant’s preliminary amendment filed 9/18/2024, is acknowledged. Claims 29-39 are new and pending.
Claim Rejections - 35 U.S.C. § 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 29-39 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility.
MPEP 2107.01(B) provides that “an application must show that an invention is useful to the public as disclosed in its current form, not that it may prove useful at some future date after further research. Simply put, to satisfy the ‘substantial’ utility requirement, an asserted use must show that the claimed invention has a significant and presently available benefit to the public.” Fisher, 421 F.3d at 1371, 76 USPQ2d at 1230. MPEP 2107.01 further provides:
Utilities that require or constitute carrying out further research to identify or reasonably confirm a “real world” context of use are not substantial utilities. For example, both a therapeutic method of treating a known or newly discovered disease and an assay method for identifying compounds that themselves have a “substantial utility” define a “real world” context of use. . . . the following are examples of situations that require or constitute carrying out further research to identify or reasonably confirm a “real world” context of use and, therefore, do not define "substantial utilities":
(A) Basic research such as studying the properties of the claimed product itself or the mechanisms in which the material is involved;
(B) A method of treating an unspecified disease or condition.
(C) A method of assaying for or identifying a material that itself has no specific and/or substantial utility;
(D) A method of making a material that itself has no specific, substantial, and credible utility; and
(E) A claim to an intermediate product for use in making a final product that has no specific, substantial and credible utility
MPEP 2107.01(B) (emphasis added).
Here, claim 29 is directed to “a method of treating a condition of a mammal.” To the extent claim is broadly directed to an unspecified disease or condition, the claim is not directed to a useful invention because it does not define a substantial utility. Even indicating that a compound may be useful in treating unspecified disorders, or that the compound has "useful biological" properties, would not be sufficient to define a specific utility for the compound. See, e.g., In re Kirk, 376 F.2d 936, 153 USPQ 48 (CCPA 1967). Claims 30-39 are rejected insofar as they depend from claim 29.
Claim Rejections - 35 USC § 102
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.
Claim(s) 29-33, 35-37 and 39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller (WO 95/23815).
Regarding claim 29, Miller relates to “the manufacture of and uses for low molecular weight agars and agaroids.” Title. Miller teaches that agaroid is water reactive and may be used with water to prepare skin preparations:
[M]ethods by which agar or an agaroid is hydrolysed under controlled conditions to give materials which form very low strength gels when 1 % solutions in water are cooled, and which, at near zero gel strengths, give dispersions which act like creams. These can be used as bases for skin treatment products, cosmetics, food and have the advantage for skin preparations of being handled like a cream but then behaving like a lotion, the cream leaving no oily residue.
Abstract. Further, Miller demonstrates in the examples that an agar composition is reconstituted with water to for a gel (current claims 30-33 and 36-37). See e.g., Examples 1. This would read on “not more than 10 volume % water . . . reacting the composition with water.”
Regarding claims 35 and 39, Miller teaches that an anti-inflammatory may be added. See page 8.
Claim(s) 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pellico (U.S. Patent No. 4,291,025).
Regarding claim 29, Pellico discloses a method of treating a condition of a mammal comprising the step of contacting an area of a mammalian body in or on the mammalian body (col 2 In 37-39 'a method for preparing a thermally reversible agar gel topical dressing'; col 6 In 63-64 'four rats were treated with the agar sol/gel') with a composition comprising an agaroid composition that is a Water Reactive Agaroid (col 2 In 38-39 'a thermally reversible agar gel topical dressing'; Water Reactive Agaroid refers to a thermally reversible gel see specification page 2 In 13-14 'The term "Water Reactive Agaroid" (WRA) as used herein refers to an agaroid composition that will form a thermos-reversible agaroid gel').
Regarding claim 30, Pellico discloses the method of Claim 29, Pellico further discloses wherein the step of contacting the area of the mammalian body with the composition causes the composition to form into a gel (col 6 In 63-64 'four rats were treated with the agar sol/gel'; col 4 In 48-51 '(b) applying the sol at a tissue compatible temperature to the burn area or other skin impairment and (c) allowing the sol to cool and reset in the form of a gel').
Regarding claim 31, Pellico discloses the method of claim 29, Pellico further discloses comprising wetting the composition with water prior to contacting the area (col 4 In 10-11 'agar, diethylene glycol and water to solubilize the agar1).
Regarding claim 32, Pellico discloses the method of Claim 29, Pellico further discloses wherein the step of contacting the area of the mammalian body (col 6 In 63-64 'four rats were treated with the agar sol/gel') comprises: administering the composition to the subject at the site of a wound or skin injury (col 4 In 48-50 '(b) applying the sol at a tissue compatible temperature to the burn area or other skin impairment').
Regarding claim 33, Pellico discloses the method of claim 29, Pellico further discloses wherein the composition is applied as a gel (col 6 In 23-25 'example shows the effect of the agar gel compositions of this invention on (a) the rate of healing and (b) bacterial growth when the gel is applied').
Regarding claim 35, Pellico discloses the method of claim 29, Pellico further discloses wherein the agaroid composition further includes an active pharmaceutical (col 3-4 In 67-68, 1-2 The gel dressings of this invention may be further formulated with special purpose ingredients...antibiotics, topical sedatives').
Regarding claim 36, Pellico discloses the method of claim 29, Pellico further discloses wherein the step of contacting an area of a mammalian body comprises applying the composition topically (col 6 In 63-64 'four rats were treated with the agar sol/gel'; col 4 In 39 'a topical gel dressing').
Regarding claim 37, Pellico discloses the method of claim 35, Pellico further discloses wherein the composition is applied as a gel (col 4 In 39 'a topical gel dressing').
Regarding claim 39, Pellico discloses the method of claim 29, Pellico further discloses wherein the composition further comprises anesthetics (col 4 In 1-2 'topical sedatives').
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 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.
Claim 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pellico (U.S. Patent No. 4,291,025) in view of Varghese (US 2013/0017232).
Regarding claim 34, Pellico discloses the method of Claim 29, but does not disclose wherein the step of contacting the area of the mammalian body includes the steps of: combining the composition with a bone supplement to form an agaroid-bone supplement mixture; and contacting a bone void or bone graft site with the agaroid-bone supplement mixture. Varghese discloses a similar agarose agaroid composition (para [0048] 'suitable hydrogels...agarose') wherein the composition is combined with a bone supplement (para [0006] 'composition comprising a hydrogel modified with amino acids') and contacting a bone void or bone graft site with the agaroid-bone supplement mixture (para [0166] 'synthetic bone graft material and implanted subcutaneously at dorsal sites in six nude rats').
It would have been obvious to one of ordinary skill in the art to combine these references at the time of this invention in order to modify the composition of Pellico to aid in bone grafting (see Varghese para [0004] 'synthesized through a biomimetic templating process and thereby effectively mimics the structure of native bone'). In this regard, it is prima facie obviousness to select a known material based on its suitability for its intended use. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function. See, e.g., In re Linder, 457 F.2d 506, 507 (CCPA 1972); see also In re Dial, 326 F.2d 430,432 (CCPA 1964).
Claim 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pellico (U.S. Patent No. 4,291,025) in view of King (US 2011/0027340 ).
Regarding claim 38, Pellico in view of King discloses the method of claim 35, King further discloses wherein the composition implanted in the mammalian body creates a drug depot (para [0011] 'an implantable drug depot for weight control').
It would have been obvious to one of ordinary skill in the art to combine these references at the time of this invention in order to modify the composition of Pellico to aid in weight control). In this regard, it is prima facie obviousness to select a known material based on its suitability for its intended use. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function. See, e.g., In re Linder, 457 F.2d 506, 507 (CCPA 1972); see also In re Dial, 326 F.2d 430,432 (CCPA 1964).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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/ROBERT S CABRAL/Primary Examiner, Art Unit 1614
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