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 .
Claims 27-30, 32, 34-36, and 38-42 remain examined on the merits while the remaining claims remain withdrawn per the election below.
Based on the amendments, the search has generated new prior art which is addressed on the record below.
As previously stated and still applicable: Applicant’s response (amendments and arguments) is acknowledged. As discussed with applicant’s representative on 5/16/25 (see attached Interview Summary), a showing of unexpected results has not been evidenced within the description/test data of record as to the amended ratios claimed (see e.g. MPEP 2144.05 II amounts/concentrations routinely optimizable absent a showing of criticality). As such, it was indicated the rejection would be maintained for the reasons of record, but that the examiner was open to weighing any further evidence. All options are being weighed by applicant, including the option of pursuing a method rather than product as the subject matter class.
The examiner remains open to interview.
Election/Restrictions – Group & Species - Maintained
Applicant’s election without traverse in the reply filed on 9/26/23 is acknowledged as to the following nutritional product:
Group II (claims 27-30, 32, 34-36, and 38-42)
Species:
Undenatured Type II collagen as the Type II collagen source:
Probiotic cell matter as the collagen adjuvant;
Probiotic organism Lactobacillus plantarum as the probiotic cell matter:
Food product as the product; and
Tablets as the formulation of the product.
The remaining claims are withdrawn as being drawn to non-elected subject matter.
[Note: The species elections though broad, have been relaxed further in the rejection below to provide teachings/suggestions within the art beyond just the elected species.].
Claim Rejections - 35 USC § 103 – Obviousness, Modified, Necessitated by Amendment
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.
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.
Claim(s) 27-30, 32, 34-36 and 38-42 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2006039768 (“Mauger” et al.; 09/17/2004) in view of CN108142630 (“Hubei”, Ltd., 06/12/18), further in view of the following related U.S. Patent Publication Nos. 20190054142 (Lugo et al.) and 20190060415 (Bellamine et al.)
Mauger teach oral nutritional products comprising collagen and pre/probiotics, such as that of Ex. 21:
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Mauger also teach employing the actual pre/probiotic organisms as part of the product (see Background).
However, Mauger does not per se teach collagen Type II or the ratios now claimed.
Hubei fills the latter gap by teaching the use of Type II collagen in ratios that fall inside that now claimed (see Abstract, Examples).
As for the new amendments, both Lugo and Bellamine teach that undenatured and denatured collagen supplements are interchangeable for joint treatment (see abstract in both):
Abstract
The present disclosure is directed to a nutritional supplement composition containing undenatured or denatured Type II collagen in combination with Vitamin A and/or one or more carotenoids. The different dietary or nutraceutical agents are capable of synergistically working together to improve the health and well-being of a human or animal. Such synergy may present as either a faster onset of action, an increase in the number of responders, or as a higher level of efficacy, or any combination thereof, as compared to the administration of the Type II collagen source, Vitamin A, or other carotenoids alone. The nutritional supplement can be used to treat joint pain or other joint ailments due to arthritis, improve immune health, improve eye health, and/or improve brain health in human and animal populations both at risk and actively presenting with such ailments.
As such, the instantly claimed invention as now claimed after amendment is deemed prima facie obvious over Mauger in view of Hubei and further in view of Lugo and Bellamine.
Response to Amendments/Arguments
Applicant’s response (amendments and arguments) is acknowledged but not yet deemed persuasive. Newly cited Lugo and Bellamine fill any gaps of Mauger in view Hubei by teaching that undenatured and denatured collagen supplements are interchangeable for joint treatment (see abstract in both). As such, the combination renders the instantly claimed invention prima facie obvious, absent more. As also discussed with applicant’s representative on 5/16/25 (see attached Interview Summary), a showing of unexpected results has not been evidenced within the description/test data of record as to the amended ratios claimed (see e.g. MPEP 2144.05 II amounts/concentrations routinely optimizable absent a showing of criticality). As such, it was indicated the rejection would be maintained for the reasons of record, but that the examiner was open to weighing any further evidence. All options are being weighed by applicant, including the option of pursuing a method rather than product as the subject matter class.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-272-5548. 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).
/MAURY A AUDET/Primary Examiner, Art Unit 1654
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