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 .
Election/Restrictions
Applicant's election with traverse of claims 1-7 in the reply filed on 03/02/2026 is acknowledged. The traversal is on the ground(s) that the asserted apparatus and method claims are not directed to independent or distinct inventions within the meaning of 35 U.S.C. § 121 and 37 C.F.R. § 1.142. The method claims expressly require use of the claimed apparatus (or an apparatus having the same functional features), and the apparatus claims are specifically configured to perform the recited method steps. The claims therefore share a common inventive concept directed to a cut-resistant compression sleeve, rely on the same disclosed structure and technical features and are functionally interrelated. The inventions are not mutually exclusive, are not capable of separate manufacture and use in any meaningful sense and would require substantially overlapping search and examination. Specifically, the process for using the product cannot be practiced with a materially different product as the product recited in Claims 1-7 are substantially claimed in the process claims. Similarly, the product as claimed cannot be used in a materially different process of using that product because the method is important to obtaining the desired and specific optimal compression.
This is not found to be persuasive because the steps of using the apparatus as claimed are very specific and would be a serious search and/or examination burden on the examiner; as for example, as to claim 8, the claim requires (1) providing at least five cut-resistant compression sleeves each of a different size, wherein each of said at least five cut-resistant compression sleeves has a main body with a wrist cuff at a first end and an arm cuff at a second end, wherein said main body has a hollow center and is made of a portion of fabric, wherein said arm cuff has an opening and said wrist cuff has an opening, wherein said portion of fabric is woven from a cut-resistant material and a sleeve material, (2) taking a measurement at least 3.2 cm to at most 6 cm below said axillary crease of said user to determine an arm cuff circumference, (3) taking a measurement at least 1.6 cm to at most 4 cm upward from said base of said thumb of said user to determine a wrist circumference, selecting at least one size using said arm cuff circumference and said wrist circumference, (4) donning said cut-resistant compression sleeve by positioning said main body over said arm of said user such that said arm cuff is at least 3.2 cm but at most 6 cm below said axillary crease of said user and said wrist cuff is at least 1.6 cm to at most 4 cm upward from said base of said thumb of said user such that said main body applies a gradient compressive force of at least 13 mm Hg and at most 18 mm Hg inwardly on said arm of said user, and (5) engaging in a repetitive movement using said arm of said user while donning said cut-resistant compression sleeve thereby reducing a risk of injury from a sharp object and reducing an amount of lactate level and an amount of cortisol level after said repetitive movement; similarly as to claim 12; the steps of use requires: (1) providing a first cut-resistant compression sleeve of a first size, a second cut- resistant compression sleeve of a second size, a third cut-resistant compression sleeve of a third 5 size, a fourth cut-resistant compression sleeve of a fourth size, a fifth cut-resistant compression sleeve of a fifth size, wherein each of said cut-resistant compression sleeves has a main body with a wrist cuff at a first end and an arm cuff at a second end, wherein said main body has a hollow center and is made of a portion of fabric, wherein said arm cuff has an opening and said wrist cuff has an opening, wherein said portion of fabric is woven from a cut-resistant material and a sleeve material, (2) taking a measurement at least 1.6 cm to at most 4 cm below an elbow crease of said elbow of said user to determine a forearm circumference, (3) taking a measurement at least 1.6 cm to at most 4 cm upward from said base of said thumb of said user to determine a wrist circumference, selecting at least one size using said forearm circumference and said wrist circumference, donning said cut-resistant compression sleeve by positioning said main body over said arm of said user such that said arm cuff is at least 1.6 cm but at most 4 cm below said elbow crease of said elbow of said user and said wrist cuff is at least 1.6 cm to at most 4 cm upward from said base of said thumb of said user such that said main body applies a gradient compressive force of at least 13 mm Hg and at most 18 mm Hg inwardly on said arm of said user, and engaging in a repetitive movement using said arm of said user while donning said cut-resistant compression sleeve thereby reducing a risk of injury from a sharp object and reducing an amount of lactate level and an amount of cortisol level after said repetitive movement. These steps of using the device are narrower than the claimed apparatus limitations and therefore, impose a serious burden to search base on separate classification; separate status in the art and a different field of search.
Furthermore, Applicant argues importantly, the product cannot be used for the prevention and treatment of secondary lymphedema, as the medical compression level begins at 20mmHg and increases thereafter. See, e.g., Exhibit A, p. 2, Compression Sleeves and Garments for Lymphedema. Breastcancer.org. Reviewed by Marcia Beck, ACNS-BC, CLT-LANA. Updated March 7, 2024. Available at: https://www.breastcancer.org/treatment-side effects/lymphedema/treatments/compression-sleeves. Accessed on March 2, 2026 (stated four pressure levels of U.S.-manufactured sleeves from 20 mmHG to 60 mmHG for treatment of lymphedema); Also see Exhibit B, p.5, first 6 pages of: Aetna Clinical Policy Bulletin.
This is not found to be persuasive as compression level required to treat secondary lymphedema depends on the severity (emphasis added) of the swelling and the limb affected (arm or leg). A lower compression range can be utilized for prevention in at-risk limbs, such as during air travel.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on 03/02/2026.
Claim Objections
Claim 1 is objected to because of the following informalities: the limitations, “A cut-resistant compression sleeve for use on an arm of a user, wherein said arm has a wrist, thumb and an elbow, comprising: a main body with a wrist cuff at a first end and an arm cuff at a second end, wherein said main body has a hollow center and is made of a portion of fabric, wherein said arm cuff has an opening and said wrist cuff has an opening, wherein said arm of said user fits into said main body through said hollow center, and wherein said fabric further comprises a weave made up of at least a series of ground yarns, a series of cut resistant yarns and a series of elastomeric inlay-yarns, and wherein said main body provides a compressive force in a range of at least 15 mm Hg and at most 18 mm Hg to said arm of said user, and wherein said compressive force is gradient with said range, applying a greater amount of pressure distally while gradually decreasing pressure as said cut-resistant compression sleeve extends upward on said arm of said user” should read, A cut-resistant compression sleeve for use on an arm of a user, wherein said arm has a wrist, thumb and an elbow, comprising:
a main body with a wrist cuff at a first end and an arm cuff at a second end, wherein said main body has a hollow center and is made of a portion of fabric, wherein said arm cuff has an opening and said wrist cuff has an opening, wherein said arm of said user fits into said main body through said hollow center, and
wherein said fabric further comprises a weave made up of at least a series of ground yarns, a series of cut resistant yarns and a series of elastomeric inlay-yarns, and
wherein said main body provides a compressive force in a range of at least 15 mm Hg and at most 18 mm Hg to said arm of said user, and
wherein said compressive force is gradient with said range, applying a greater amount of pressure distally while gradually decreasing pressure [[as]] when said cut-resistant compression sleeve extends upward on said arm of said user. Appropriate correction is required.
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.
Claim 3 is 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.
The term “proximate” in claim 3 is a relative term which renders the claim indefinite. The term “proximate” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-7 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
As to claim 1, the limitation, “wherein said arm of said user fits into said main body through said hollow center” and “wherein said main body provides a compressive force in a range of at least 15 mm Hg and at most 18 mm Hg to said arm of said user”; positively recites part of the human body;
As to claim 3, the limitation, “wherein said main body has a relief stitch proximate said elbow of said user”; positively recites part of the human body;
As to claim 4, the limitation, “wherein said user further comprises an axillary crease and wherein said upper end of said arm cuff is positioned at least 3.2 cm to at most 6 cm below said axillary crease of user”; positively recites part of the human body;
As to claim 5, the limitation, “wherein said arm cuff is positioned at least 1.6 to at most 4 cm below an elbow crease of said elbow”; positively recites part of the human body.
To obviate a rejection under 35 USC 101, the Office suggests that any claim that would include a human being, or part thereof, within its scope should use “configured to” or configured for” to define the metes and bounds of the claimed subject matter which is a permissible form of expression.
Claims 2 and 6-7 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism since they depend directly or indirectly on rejected base claim 1 and therefore contain the same deficiencies.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786