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 .
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 1-6 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is drawn to the compound of formula I which is a disaccharide bracketed by “n”; however “n” is not defined in the claim thus rendering the claim indefinite for not defining the variables set forth in the claim.
Claim 1 is confusing as directly under the formula I the claim states that at least one R1 represents -R7-N+(R8)(R9)(R10)X- and the other R1’s are each H. Then, later in the claim formula II has R1 groups; and formula III has R1 groups. Since the “at least one R1 represents -R7-N+(R8)(R9)(R10)X-” is in the claim before formulas II and III, it leaves confusion if the “at least one R1 represents -R7-N+(R8)(R9)(R10)X-” is only for formula I, or this N-containing group can be on any of formulas I, II, or III. The examiner notes that if this can be on any of formulas I-III, the claim would be better drafted as R1 is -R7-N+(R8)(R9)(R10)X- or H; then at the end of the claim adding that “wherein at least one R1 represents -R7-N+(R8)(R9)(R10)X-”.
In claim 1, the definition for R8, R9, and R10 is confusing. The claim states that these groups are the same or different C1-6 alkyl, C1-6 alkenyl, O-C1-6 alkyl, and heteroalkyl or heteroalkenyl denoted by CaYb where Y is a heteroatom and a+b is 4-6, and in a case of a nitrogen atom being a binding site, a saturated or unsaturated five- or six-membered ring containing the nitrogen atom is formed. This is confusing in numerous ways. How can the R-groups be the same or different if they are C1-6 alkyl, C1-6 alkenyl, O-C1-6 alkyl, and heteroalkyl? The “and” requires all of these groups present together. Likewise, does applicant mean they are the same or different C1-6 alkyl, C1-6 alkenyl, O-C1-6 alkyl, or heteroalkyl; or heteroalkenyl denoted by CaYb…; or they are the same or different C1-6 alkyl, C1-6 alkenyl, O-C1-6 alkyl, or heteroalkyl or heteroalkenyl denoted by CaYb?
Further, in claim 1 – does the CaYb- group intend to also include any H-atoms, as C4O2 reads on applicants claims, but would not be a stable or expected compound.
Additionally, in the definition of R8, R9, and R10, when applicants state “in a case of a nitrogen atom being a binding site, a saturated or unsaturated five- or six-membered ring containing the nitrogen atom is formed, what nitrogen are applicants referring to. All of R8, R9, and R10 are connected to N, and thus would use N as a binding site – does applicant intend for there to always be a N-containing ring, and if so do two of R8, R9, and R10 form this ring with the N-they are attached to and the other R-group remain as one of the alkyl, alkenyl, etc groups?
All claims which depend from an indefinite claim are also indefinite. Ex parte Cordova, 10 U.S.P.Q. 2d 1949, 1952 (P.T.O. Bd. App. 1989).
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over WO00/005269.
The claims of the present application are drawn to hemostatic material comprising a cationic polysaccharide of formula I. Dependent claims provide formula I is optionally a cationic guar gum wherein the cationic guar gum is guar hydroxypropyltrimonium chloride or hydroxypropyl guar hydroxypropyltrimonium chloride.
‘269 is drawn to hemostatic compositions comprising a non-protein cationic component (see abstract). The cationic component is taught to be guar gum hydroxyproplytrimonium chloride (see 1st paragraph of page 4; claim 7). The compositions are taught to be used in hemostatic preparations (see pages 41-42, example K). What is not specifically exemplified is the guar gum hydroxyproplytrimonium chloride hemostatic material claimed herein.
However, it would have been obvious to one of skill in the art to make the hemostatic material with guar gum hydroxyproplytrimonium chloride as claimed herein as it is specifically suggested to do the same in ‘269. ‘269 states that their complexes enhance the hemostatic effects of the final products based on the properties of the temporary wound cover formed after the hemostasis is achieved such as its flexibility and resistance to cracking on movable parts of the body (see page 6). One would have been motivated to make the hemostatic material comprising guar gum hydroxyproplytrimonium chloride as claimed herein as ‘269 suggests to do the same to enhance the hemostatic effects of the products.
Claim(s) 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over WO00/005269 in view of WO2017/060821 and Yuan et al. (Industrial and Engineering Chemistry Research, 2019, vol. 58, pp 9390-9396).
The claims of the present application are drawn to hemostatic material comprising a cationic polysaccharide of formula I. Dependent claims provide formula I is optionally a cationic guar or xanthan gum wherein the cationic guar or xanthan gum is guar hydroxypropyltrimonium chloride, hydroxypropyl guar hydroxypropyltrimonium chloride, xanthan hydroxypropyltrimonium chloride or hydroxypropyl xanthan hydroxypropyltrimonium chloride.
‘269 is drawn to hemostatic compositions comprising a non-protein cationic component (see abstract). The cationic component is taught to be guar gum hydroxyproplytrimonium chloride (see 1st paragraph of page 4; claim 7). The compositions are taught to be used in hemostatic preparations (see pages 41-42, example K). What is not specifically exemplified is the guar gum hydroxyproplytrimonium chloride hemostatic material, nor the xanthan gum derivatives claimed herein.
‘821 teaches hemostatic compositions comprising xanthan and/or guar gum.
Yuan teaches that cationic polysaccharides with quaternary ammonium functional groups (guar hydroxypropyltrimonium chloride – see figure 1) have unique properties such as stabilizing, suspending, wetting, lubricating, and antibacterial. Yuan notes that because of the biocompatible and biodegradable nature, these cationic polysaccharides are extensively used in a wide range of applications, such as wound adhesives (see 1st paragraph of introduction on page 9390).
As such, the xanthan gum hydroxypropyltrimonium chloride hemostatic material claimed herein would be prima facia obvious in view of above. ‘269 teaches hemostatic compositions comprising guar gum hydroxypropyltrimonium chloride; Yuan teaches that cationic polysaccharides with the same hydroxypropyltrimonium chloride group provide good wound adhesives; and ‘821 discloses hemostatic compositions with guar gum and/or xanthan gum. It would be obvious to make a hemostatic material with the functionally important cationic hydroxypropyltrimonium chloride group using xanthan gum with these references before them, as they teach all of the features individually are effective for use for the same – hemostatic agents.
Conclusion
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TRAVISS C. MCINTOSH III
Primary Examiner
Art Unit 1693
/TRAVISS C MCINTOSH III/ Primary Examiner, Art Unit 1693