Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of the application
2. Claims 1-7 are pending in this office action.
Claims 1-7 have been rejected.
Claim Rejections - 35 USC § 102/103
3. The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
4. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
5. Claims 1, 2, 4 and 7 are rejected under pre-AIA 35 U.S.C. 102(b) as anticipated by Mateus et al. USPN 2011/0250310 or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Mateus et al. USPN 2011/0250310.
6. Regarding claim 1, Mateus et al. discloses that 100 gm total composition can include carbohydrate (at least in [0098]), protein content at least about 8gm/100gm ([0018]), can be whey protein micelle concentrate (at least in [0080], [0106], Ex 2, [0134]) and fiber in the composition ([0047], [0112]) and the amounts of the ingredients are based on the total weight of the composition.
It is understood that Mateus et al. discloses a non-therapeutic method comprising administering a whey protein micelles (WPM) composition to the subject which anticipates claim 1. This disclosed non-therapeutic method of administration of WPM is identical to the claimed WPM and therefore, the disclosed WPM composition will have the identical claimed property “to decreases plasma post prandial insulin and/or plasma postprandial glucagon concentration in a subject”. Therefore, Mateus et al. anticipates claim 1.
7. Regarding claim 2, Mateus et al. discloses that the subject is a human or animal ([0073]). Therefore, Mateus anticipates claim 2.
8. Regarding claim 4, Mateus et al. discloses that the nutritional composition can be a shelf-stable, neutral, whey protein micelle containing (at least in Example 2, [0134]) nutritionally balanced meal replacement composition ([0129]). Therefore, Mateus et al. anticipates claim 4.
9. Regarding claim 7, claim 7 depends on claim 4. Therefore, the rejection made for claim 4 is applicable to claim 7 also. In addition, Mateus et al. discloses that the liquid meal replacement comprising whey protein micelle is a nutritional composition which can be used as enteral non-gel liquid composition (at least in [0052]). Therefore, Mateus et al. anticipates claim 7.
However, the recitation in the claim 7 that “ for use in enteral nutrition”’ is merely an intended use. Applicants’ attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Mateus et al., discloses “for its use as oral composition”, it is clear that the whey micelle containing nutritional composition of Mateus et al. would be capable of performing the intended use, i.e. ‘for use in an enteral nutrition’, presently claimed 7 as required in the above cited portion of the MPEP, and thus, Mateus et al. anticipates claim 7.
Therefore, Mateus et al. anticipates claims 1, 2, 4 and 7.
Or, in the alternative
10. Regarding claim 1, Mateus et al. discloses that 100 gm total composition can include carbohydrate (at least in [0098]), protein content at least about 8gm/100gm ([0018]), can be whey protein micelle concentrate (at least in [0080], [0106], Ex 2, [0134]) and fiber in the composition ([0047], [0112]) and the amounts of the ingredients are based on the total weight of the composition.
It is understood that Mateus et al. discloses a non-therapeutic method comprising administering a whey protein micelles (WPM) composition to the subject which meets claim 1. This disclosed non-therapeutic method of administration of WPM is identical to the claimed WPM and therefore, the disclosed WPM composition will have the identical claimed property “to decreases plasma post prandial insulin and/or plasma postprandial glucagon concentration in a subject”. Therefore, it would have been obvious that Mateus et al. meets claim 1.
11. Regarding claim 2, Mateus et al. discloses that the subject is a human or animal ([0073]). Therefore, Mateus et al. meets claim 2.
12. Regarding claim 4, Mateus et al. discloses that the nutritional composition can be a shelf-stable, neutral, whey protein micelle containing (At least in Ex 2, [0134]) nutritionally balanced meal replacement composition ([0129]). Therefore, Mateus et al. meets claim 4.
13. Regarding claim 7, the rejection made for claim 4 is applicable to claim 7 as claim 7 depends on claim 4. In addition, Mateus et al. discloses that the liquid meal replacement comprising whey protein micelle is a nutritional composition which can be used as enteral non-gel liquid composition (at least in [0052]).
14. However, the recitation in the claim 7 that “ for use in enteral nutrition”’ is merely an intended use. Applicants’ attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Mateus et al., discloses “for its use as oral composition”, it is clear that the whey micelle containing nutritional composition of Mateus et al. would be capable of performing the intended use, i.e. ‘for use in an enteral nutrition’, presently claimed as required in the above cited portion of the MPEP, and thus, one of ordinary skill in the art would have arrived at the claimed invention.
15. Claims 1, 2, 4, 7 are rejected under pre-AIA 35 U.S.C. 102 (b) as anticipated by Bovetto et al. USPN 2009/0035437 or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Bovetto et al. USPN 2009/0035437.
16. Regarding claims 1, 2, 4, 7 Bovetto et al. discloses that whey protein is used to control diabetes by controlling blood glucose of children, elderly and adult human individual ( [0065], [0066]) and whey protein is an excellent source of amino acids ([0064]) and is used in many diet composition ([0097], e.g. diet fortification, etc.) in the form of whey protein micelle which is superior form of whey protein derivative in relation to its stability, taste etc. ([(0133]) and restoring the excellent protein quality equivalent to the starting whey protein from which it is derived ([O066], it is evaluated by PER value which is 100-110 e.g. in [(0108]) and it can be used as WPM concentrate as WPM powder having pure WPM ([0100], [0106] e.g. at least 50% WPM can be 100% also ([0106]). It is understood that Bovetto et al. discloses a non-therapeutic method comprising administering a whey protein micelles (WPM) composition to the subject which anticipates claim 1. Therefore, Bovetto et al. anticipates claims 1, 2. This disclosed non-therapeutic method of administration of WPM is identical to the claimed WPM and therefore, the disclosed WPM composition will have the identical claimed property “to decreases plasma post prandial insulin and/or plasma postprandial glucagon concentration in a subject”. Therefore, Bovetto et al. anticipates claim 1.
Bovetto et al. also discloses that the solution may also contain other food ingredients (fat, carbohydrates, plant extracts, etc) ([0068]). Therefore, the composition can be used to replace meal to serve as meal replacement composition which anticipates claim 4 .
Regarding claim 7, the rejection made for claim 4 is applicable to claim 7 as claim 7 depends on claim 4. In addition, It is to be noted that claim 7 is also intended use and addressed below. It is to be noted that claim 7 is also intended use and addressed below.
17. However, the recitation in the claim 7 that “ for use in enteral nutrition”’ is merely an intended use. Applicants’ attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Bovetto et al., discloses “for its use as oral composition”, it is clear that the whey micelle containing nutritional composition of Bovetto et al. would be capable of performing the intended use, i.e. ‘for use in an enteral nutrition’, presently claimed 7 as required in the above cited portion of the MPEP, and thus, Bovetto et al. anticipates claim 7.
Or, in the alternative
18. Regarding claims 1,2, 4 and 7, Bovetto et al. discloses that whey protein is used to control diabetes by controlling blood glucose of children, elderly and adult human individual ( [0065], [0066]) and whey protein is an excellent source of amino acids ([0064]) and is used in many diet composition ([0097], e.g. diet fortification, etc.) in the form of whey protein micelle which is superior form of whey protein derivative in relation to its stability, taste etc. ([(0133]) and restoring the excellent protein quality equivalent to the starting whey protein from which it is derived ([0066], it is evaluated by PER value which is 100-110 e.g. in [(0108]) and it can be used as WPM concentrate as WPM powder having pure WPM ([0067], [0100], [0106] e.g. at least 50% WPM can be 100% also ([0106]) Therefore, Bovette et al. anticipates claims 1, 2. This disclosed non-therapeutic method of administration of WPM is identical to the claimed WPM and therefore, the disclosed WPM composition will have the identical claimed property “to decreases plasma post prandial insulin and/or plasma postprandial glucagon concentration in a subject”. Therefore, it would have been obvious that Bovetto et al. meets claim 1.
Bovetto et al. also discloses that the solution may also contain other food ingredients (fat, carbohydrates, plant extracts, etc.) ([0068]). Therefore, it would have been obvious that the composition can be used to replace meal to serve as meal replacement to meet claim 4.
19. Regarding claim 7, the rejection made for claim 4 is applicable to claim 7 as claim 7 depends on claim 4. In addition, It is to be noted that claim 7 is also intended use and addressed below.
However, the recitation in the claim 7 that “ for use in enteral nutrition”’ is merely an intended use. Applicants’ attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Bovetto et al., discloses “for its use as oral composition”, it is clear that the whey micelle containing nutritional composition of Bovetto et al. would be capable of performing the intended use, i.e. ‘for use in an enteral nutrition’, presently claimed as required in the above cited portion of the MPEP, and thus, one of ordinary skill in the art would have arrived at the claimed invention.
Claim Rejections - 35 USC § 103
20. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
21a. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person Application/Control Number: 14/353,188 Page 3 Art Unit: 1792 having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
21b. The factual enquiries 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(a) 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.
22. Claim 5 is rejected under 103(a) as obvious over Mateus et al. USPN 2011/0250310.
Claim 5 is relied upon as above.
23. Regarding claim 5, Mateus et al. discloses that the nutritional composition can be a shelf-stable, neutral, whey protein micelle (WPM) containing at least 13.5 gm/100gm ([0134]) nutritionally balanced meal replacement composition ([0129]). It would have been obvious that the disclosed range amounts of WPM overlap with the claimed range amount of “at least 15 wt.% of the liquid replacement meal showing prima facie case of obviousness.
24. Claims 3, 6 are rejected under 103 (a) as obvious over Mateus et al. USPN 2011/0250310 as applied to claims 1 and 4 and further in view of Gahler et al. US 2008/0027024.
25. Regarding claims 3, 6, Mateus et al. discloses that 100 gm composition can include
(a) carbohydrate is 10 g/100 gm ([0098]),
(b) the disclosed amount of protein content can be 100% whey protein content ([0018]) and it can be at least about 8gm/100gm ([0018]) can be at least about 8gm/100gm whey protein micelle (at least in [0018], [0106]),
(c) fat 0-12g/100 gm ([0023], [(0099]), and
(d) fiber in the composition ([0047], [0112]).
Mateus et al. is silent about (i) amount of fiber.
Gahler et al. discloses that fiber blend is administered as dietary supplement ([0061]) in the nutritional composition used as food ([0088]) is used to lower blood glucose (Abstract, [0012]) and lower glycemic index which controls diabetes ([0046]- [0049], [0092], [0097] e.g. fiber and “glucose monitoring’, [0106], [0107], [0130]). Gahler et al. also discloses that the amount of fiber can be 5-15 g/day ([0098], [0099]) and it is 2.5- 7.5 g fiber/50 gm carbohydrate ([0087]- [0089]).
One of ordinary skill in the art would have been motivated to modify Mateus et al. to include the teaching of Gahler et al. to incorporate the fiber blend (FB) in the composition as a source of fiber in the nutritional composition and also the fiber blend composition is effective to reduce blood glucose (Abstract, [0002] of Gahler et al.) and to control obesity ([0046]-[0049], [0106], [0107], [0130]) and a loss in body fat, reduced body weight, [0130], [0131 ]). Therefore, Mateus et al. in view of Gahler et al. meet the amounts of all the ingredients as claimed in claims 3, 7.
It is also to be noted that it is within the skill of one of ordinary skill in the art to optimize the amount of number of meals having “7.2% of the whey micelle containing meal’ is needed (Bell teaches it can be at least once a day [0008]) to have ‘at least 30 gm dry weight of whey protein micelle’ of claim 1 in order to the plasma postprandial insulin and plasma postprandial glucagon’ concentration in human individual.
It is to be noted that Mateus et al. discloses that the protein can be about 8.0 gm/100 gm ([0018], [0019]) and it can be 100% whey protein also ([0022]).
However, the claim recites “about 7.2 wt. % of the whey protein micelle’.
Regarding protein content (b) above, the disclosed amount of whey protein micelle content of at least about 8gm/100gm ([0018]) and about 7.2% WPM, is very close.
The only deficiency of Mateus et al. is that Mateus et al.disclose the use of at least about 8% by weight while the present claims require about 7.2% by weight.
It is apparent, however, that the instantly claimed amount of 7.2% by weight and that taught by Mateus et al. are so close to each other that the fact pattern is similar to the one in In re Woodruff , 919 F.2d 1575, USPQ2d 1934 (Fed. Cir. 1990) or Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed.Cir. 1985) where despite a “slight” difference in the ranges the court held that such a difference did not “render the claims patentable” or, alternatively, that “a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough so that one skilled in the art would have expected them to have the same properties”.
In light of the case law cited above and given that there is only a “slight” difference between the amount of 8% by weight disclosed by Mateus et al.and the amount disclosed in the present claims, it therefore would have been obvious to one of ordinary skill in the art that the amount of about 7.2% by weight of whey protein micelle disclosed in the present claims is but an obvious variant of the amounts disclosed in (reference name), and thereby one of ordinary skill in the art would have arrived at the claimed invention.
26. Regarding claim 6, in addition to rejection made for claim 6 above, the following paragraphs should be additionally considered.
Claim 6 depends on claim 4. Claim 4 claims meal replacement. Therefore, it is to be noted that it is within the skill of one of ordinary skill in the art to optimize the amount of number of meals having “7.2 wt.% of the whey micelle containing meal’ is needed (Bell teaches it can be at least once a day [0008]) to have ‘at least 30 gm dry weight of whey protein micelle’ of claim 1 in order to the plasma postprandial insulin and plasma postprandial glucagon’ concentration in human individual.
It is to be noted that the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Conclusion
27. Any inquiry concerning the communication or earlier communications from the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful, examiner's supervisor Erik Kashnikow, can be reached on 571-270-3475. 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.
/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792
Prosecution Insights