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 .
Status of the Application
Claims 1-5, 8, 10-15 are pending and under current examination.
Amendment necessitated new claim rejection as set forth below.
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 1-5, 8, 10-15 are rejected under 35 U.S.C. 112(b), 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.
Claims 1-5, 8, 10-15 are indefinite as:
Claim 1 is indefinite as the claim recites “time period between day 1 and 7 of life”, as it is unclear if this time period refers to when the administration started or refers to treatment time period. For compact prosecution, the claim has been interpreted as referring to “when the administration started”.
Since the dependent claims doesn’t cure the above deficiency, these claims are also indefinite.
Appropriate correction required.
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 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 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 8, 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Morrow (US 2018/0153915 A1) and Garcia-Rodenas (WO2019/122190 A1; as provided by the applicant on IDs dated 06/02/2023) in combination.
Determining the scope and contents of the prior art
Morrow discloses with examples a method for reducing the time to reach full enteral feeding in preterm infants, such as born before 37 weeks of pregnancy, or at 29 weeks of pregnancy etc. with weight, such as less than 2500g, less than 1000g etc., and increasing weight (thus a fortifier, supplement etc.) comprising administering aqueous composition comprising HMO 2’FL, such as in concentration 10%, 15%, 20,% 25% by weight along with buffers (pH modifier) or a composition comprising 2’FL HMO only (a neutral oligosaccharide, therefore at pH7) (entire application, especially paragraphs 0024, 0045, 0058, 0062,0077-0079, 0081, 0082, 0083, 0092-0094, 0096, 0102, 0107, 0109-0113, 0120-0138, 0143, 0144 0187 Figures 5, 25, 26, 37, 39).
Since the infant is preterm and cannot have enteral feeding, the feeding of the composition is expected to be started on day 1 of life or at least between days 1 and 7 of life. In addition, the cited prior art discloses that the time of full enteral feeding is reduced to 3, 4, --10, 11 days etc. (meets limitation of at least two days), which again implies that the feeding of the composition must be started before 10 days of life.
The cited prior art further teaches feeding human milk containing HMO 2’FL to preterm infant at day 1 of life, which again reads on limitation of between days 1 and 7 of life (see Fig 26):
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Since Fig 26 has composition as human milk, the pH of the composition is 4 to 7. In addition, as the cited art composition is same as in the instant claims with same HMO and pH, the pH modulator resulting in such pH is also expected to be the same, whether or not recognized by the cited prior art.
Since the preterm baby is same as in the instant claims, the standard of minimum enteral intake of the baby is expected to be same and recommended my pediatrics.
Garcia-Rodenas discloses with examples a method for promotion of enteral feeding tolerance (i.e., reducing the time to reach full enteral feeding) in preterm infants by promotion of intestinal muscle growth and intestinal motility, such as born before 37 weeks of pregnancy, or at 29 weeks of pregnancy etc. comprising administering aqueous fortifier, supplement composition immediately after birth or first week of life comprising HMO 2’FL, and LNnT etc., along with buffering agent (pH modifier) or a composition comprising only HMO 2’FL (neutral oligosaccharide and therefore pH 7), or a composition comprising only HMO LNnT or a composition comprising only two HMO 2’FL, and LNnT at ratio of 10:1 (example 4) with no other nutrient:
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(entire application, especially abstract, pages 1-3, 4-8, 12-18, 21, 26, 27, 31, examples 3 and 4). Since the preterm baby is same as in the instant claims, the standard of minimum enteral intake of the baby is expected to be same and recommended my pediatrics.
Ascertaining the differences between the prior art and the claims at issue
Morrow discloses with examples a method for reducing the time to reach full enteral feeding in preterm infants, such as born before 37 weeks of pregnancy, or at 29 weeks of pregnancy etc. with weight, such as less than 2500g, less than 1000g etc., and increasing weight (thus a fortifier, supplement etc.) comprising administering aqueous composition comprising HMO 2’FL, such as in concentration 10%, 15%, 20,% 25% by weight along with buffers (pH modifier) or a composition comprising 2’FL HMO only (a neutral oligosaccharide, therefore at pH7), but fails to teach the process with combination of 2’FL and LNnT.
Garcia-Rodenas discloses with examples a method for promotion of enteral feeding tolerance (i.e., reducing the time to reach full enteral feeding) in preterm infants by promotion of intestinal muscle growth and intestinal motility, such as born before 37 weeks of pregnancy, or at 29 weeks of pregnancy etc. comprising administering aqueous fortifier, supplement composition immediately after birth or first week of life comprising HMO 2’FL, and LNnT etc., along with buffering agent (pH modifier) or a composition comprising only HMO 2’FL (neutral oligosaccharide and therefore pH 7), or a composition comprising only HMO LNnT or a composition comprising only two HMO 2’FL, and LNnT at ratio of 10:1, but fails to teach total concentration of 2’FL, and LNnT in the composition.
Resolving the level of ordinary skill in the pertinent art
With regards to the above difference -Morrow discloses with examples a method for reducing the time to reach full enteral feeding in preterm infants comprising administering aqueous composition comprising HMO 2’FL, such as in concentration 10%, 15%, 20%, 25% by weight. In the same field of endeavor, Garcia-Rodenas discloses with examples a method for promotion of enteral feeding tolerance (i.e., reducing the time to reach full enteral feeding) in preterm infants by promotion of intestinal muscle growth and intestinal motility, such as born before 37 weeks of pregnancy, or at 29 weeks of pregnancy etc. comprising administering aqueous fortifier, supplement composition immediately after birth or first week of life comprising HMO 2’FL, and LNnT etc., along with buffering agent (pH modifier) or a composition comprising only HMO 2’FL (neutral oligosaccharide and therefore pH 7), or a composition comprising only HMO LNnT or a composition comprising only two HMO 2’FL, and LNnT at ratio of 10:1. Thus, with the guidance provided by Morrow and Garcia-Rodenas, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that 2’FL and LNnT individually or in combination in ratio 10:1 is useful in reducing the time to reach full enteral feeding in preterm infants. Further, Morrow teaches concentration of 2’FL as 10%, 15%, 20%, 25% by weight. Thus, considering concentration taught by Morrow and combination 2’FL and LNnT in ratio 10:1 taught by Garcia-Rodenas, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that concentration of 2’FL and LNnT in combination has to be in range 11%----35%. Thus, the cited prior art meets limitation of the instant claims.
Based on the above established facts, it appears that the combination of teachings of above cited prior art read applicants’ process.
Therefore, all the claimed elements were known in the prior art and one skilled person in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Morrow discloses with examples a method for reducing the time to reach full enteral feeding in preterm infants comprising administering aqueous composition comprising HMO 2’FL, such as in concentration 10%, 15%, 20%, 25% by weight. In the same field of endeavor, Garcia-Rodenas discloses with examples a method for promotion of enteral feeding tolerance (i.e., reducing the time to reach full enteral feeding) in preterm infants by promotion of intestinal muscle growth and intestinal motility, such as born before 37 weeks of pregnancy, or at 29 weeks of pregnancy etc. comprising administering aqueous fortifier, supplement composition immediately after birth or first week of life comprising HMO 2’FL, and LNnT etc., along with buffering agent (pH modifier) or a composition comprising only HMO 2’FL (neutral oligosaccharide and therefore pH 7), or a composition comprising only HMO LNnT or a composition comprising only two HMO 2’FL, and LNnT at ratio of 10:1.
So, the combination of prior art read applicants claims.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. It is well within the skill of the organic chemist to recognize the fact that applicants claimed process is nothing but the combination of known individual chemical processes. Further, there is a reasonable expectation of success that 2’FL and LNnT individually or in combination in ratio 10:1 is useful in reducing the time to reach full enteral feeding in preterm infants and can be made by combination of the above cited prior art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed process with a reasonable expectation of success. Modifying such parameters is prima facie obvious because an ordinary artisan would be motivated to develop an alternative process for economic reasons or convenient purposes from a known individual reaction steps, and to arrive applicants process with a reasonable expectation of success, since it is within the scope to modify the process through a routine experimentation.
Response to Arguments
Applicant’s remarks and amendment, filed on 01/30/2026, have been fully considered but not found persuasive.
Applicant’s argument is moot in view of new rejection as set forth above.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Conclusion
No Claim is allowed.
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/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623
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